Method For Manufacturing Molded Article With Core

ABSTRACT

A method for manufacturing molded articles with cores uses a compression molding apparatus that includes upper and lower punches that have a double structure comprising a central punch and an outer punch that surrounds the periphery of the central punch. The central punch and the outer punch are movable and capable either of moving together or sliding with respect to one another. Molding materials are supplied for a core and an outer layer. The molding materials are compressed by the punches to form molded articles that include the core. The method may be executed in a rotary compression molding machine.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.10/317,360, having a filing date of Dec. 12, 2002, now pending, which isa continuation of International Application PCT/JP2001/05296, having aninternational filing date of Jun. 20, 2001, now abandoned, which claimspriority to Japan Application Nos. 2000-183996, filed Jun. 20, 2000,2000-387052, filed Dec. 20, 2000, 2001-42787, filed Feb. 20, 2001,2001-74413, filed Mar. 15, 2001, 2001-98571, filed Mar. 30, 2001, and2001-125690, filed Apr. 24, 2001. Further, International ApplicationPCT/JP2001/05296, was filed in the national stage of Japan as JapanApplication No. 2002-503525, which issued as Japan Patent No. 4316871 onMay 29, 2009. All of which are hereby incorporated herein by reference.

TECHNICAL FIELD

The present invention relates generally to a manufacturing method formanufacturing a molding by compressing molding material such as powdergranule, an apparatus for use in the method, and a molding which is theproduct thereof, and more particularly, to a method for manufacturing amolding with core, a rotary compression molding machine for use inpracticing the method, and a molding with core which is the productthereof.

BACKGROUND ART

The method to manufacture a molding by compacting molding materialrepresented by powder granule, etc., has widely been used in variousindustrial fields for example not only in the field of medicines andfoods (functional foods and general foods), but also in the field ofelectronic material such as semiconductor sealing resin molding, moldingof battery related products, molding of powder metallurgy relatedproducts, and molding of electronic functional parts as well as in thefield of agricultural chemicals and sanitary products.

In the field of medicines, especially in case of medicines for oraladministration, a solid molding called “tablet” is one of the mostwidely used form of medicines, because of their various merits, e.g.,they are simple to manufacture and easy to take. Among them, a moldinghaving core therein is called compression-coated tablet because it iseach manufactured by distributing and compacting the powder granule asan outer layer around the core (center tablet).

Since the compression-coated tablet having a core therein can separatemedicines that undergo change of formulation into the core and the outerlayer, an improved stability is expected due to low probability ofcontact between medicines. Besides the compression-coated tablet presentan effective way to mask bitter taste of core and improve appearance oftablet, as well as to protect against damaging environmental factors(such as light or humidity). They can also be used as release controlledmedicines that include an outer layer having a rapid releasability and acore in the form of an enteric tablet or a sustained release tablet.

Up until now, when manufacturing a molding with core such as acompression-coated tablet, the core was made as a molded piece inadvance in a separate tableting machine, then it was moved to a die of adifferent compression-coated tablet machine where the powder granuleforming the outer layer was fed and then compressed. For this reason,compared to the typical method for manufacturing compression moldings,this method presents some serious problems such as more steps and lowproductivity. Besides, in this conventional method feeding cores asmolded pieces, since the molded pieces as cores are to be fed one by onein the die of a rotary table which revolves at a high speed, sometimes acore may not be fed and sometimes they may be fed in excess andtherefore problems such as manufacturing of products without core orproducts with plural cores occur easily. For this reason, in order topreserve quality, there appear a necessity for complicated mechanismsand systems for surveillance of the feeding of core and inspection ofthe final molding. Thus the machines engaged in the process ofmanufacturing of a molding with core become larger in size and morecomplicated.

Besides, in the traditional method of feeding the core, it was importantthat the core was horizontally disposed in the middle of the outer layerpowder granule within the die and then compression-molded. For thisreason some moldings disorders occur very easily. For example when thecore is not in the middle, the outer layer becomes thinner in thatregion; also the capping occurs because of decline in the moldability.Another disorder is a lamination when cracks on the surface of themolding appear in layers.

In order to prevent offset in the centering of the core due to thecentrifugal force of the rotary table, Japanese Patent Laid-open Pub.No. Sho55-48653 discloses an inspection method of the centering of thecore by visual inspection after it is fed; Japanese Patent Laid-openPub. No. Sho61-60298 discloses a system provided with amulti-optical-axis identification sensor in conjunction with core feederto automatically correct the core position; and Japanese patentLaid-open Pub. No. Hei9-206358 discloses a method for preventing theoffset in the core centering by use of a system for automaticallycorrecting the core feeding positions on the basis of informationacquired from a CCD imaging device.

However, even when the above core centering systems are used, problemsof precision of the centering and stability of feeding of cores stillremain unsolved and therefore step of the high-speed rotary table as inthe ordinary tableting machines (40 to 60 rpm) is difficult, so theactual operating ability is limited to approx. 30 rpm and theproductivity is low.

In regard to the size of a molding with core, in the conventionalmethod, due to dispersions in the core centering and to insufficientadhesion strength between the core and the outer layer which may arisefrom utterly separate molding of the core and the outer layer, the outerlayer minimum thickness of 1 to 1.5 mm is required, and inevitably, amolding with core becomes at least 2 to 3 mm larger than the coreitself. Therefore compared to coreless a molding, the molding with corehas the tendency to become larger, which is an obstacle in the effortsto miniaturize the molding.

As far as the shape of core is concerned, in the traditional method inwhich cores are externally fed, it is necessary to provide a dedicatedfeeder, conforming to the shape of the core. Therefore, whenmanufacturing a molding with diversely shaped cores, a diversity of corefeeder is needed and the problem of lacking in versatility still remainsleft.

In the traditional method, since a core prepared beforehand is fed, itis necessary for the cores to have moldability that will allow anharmless delivery through a supply line into the die, as well as shapethat will allow smooth passage. Therefore there are some limitations inthe shape and properties of the core. For example, the traditionalmethod does not provide a way to manufacture a molding having a corethat is not the solid or a core that is the very powder granule.

As far as the shape of the punch in the prior art is concerned,different types of punches are used, depending on the shape of themolding to be compressed. In some instances, punches with specific shapeare used. For example, in case of a troche-shaped molding, used inmedical field, in which the central part is cut out, it is verydifficult to fill in evenly the powder granule, using an ordinary punch.Also, to open the central part, a so-called ring-punch, or a doublepunches is used for the compression molding.

When manufacturing extremely small and complex in a shape molding usedin diverse applications including electronic parts, due to thecomplexity in the shape, there is a difference in the compression ratioof the powder granule. Because of this difference, the molded productsmay have largely different powder granule densities, depending on thesites, with the result that the molding is easily broken or damaged.Thus, in order to solve these problems, a method has been executed inwhich powder granule is filled in such that the powder granule densitiesof the molding are the same by separately moving the bottom center punchand the lower outer punch, of multiple punches having the same structureas the ring punch which is seen in the lower punch structure of therotary powder compression molding machine disclosed in Japanese PatentLaid-open Pub. No. Sho52-126577.

However, the conventional so-called ring punch, i.e., punch having amultiple-structure is used as an additional aid for filling the powdergranule and to secure ring-shaped cavities and that is why it isutilized mainly as lower punch. Even the center punch is used instationary mode.

The manufacturing methods and apparatus for molding having a single coreare subjected to the above situations and problems. However, in regardto a molding having plural cores, since in the state of the art anyrotary tableting machines that can manufacture such a molding does notexist, there are no prior art of practical use.

In terms of references, Japanese Patent Pub. No. Hei2-243158 describes amethod for reducing the size of a compression-coated tablet byintroducing plural small-sized core pellets into a single die. However,in addition to involving the above situations and problems of themolding with single core, there are some new problems due to increase inthe manufacturing process steps. For example, there also increases thefrequency of manufacturing of a molding without core or with more thanone core as set forth above. In other instances, due to interferenceamong cores in the die, the positions of different cores are notconsistent, but are different for each molding.

Following is a reference to the prior art related to a molding.

As described above, the method to manufacture compression-coated tabletsconsisted of feeding cores, prepared in advance in a different tabletingmachine, into a die, feeding the outer layer around the core and thenapplying compression. For this reason, the core was restricted by somephysical factors, mainly the moldability (friability and hardness) forallowing the supply into the die. Therefore due to problems of handlingand poor feeding ability of the core caused by wearing away of cores,only cores with high moldability were used in this method.

In order to change the formulation to improve moldability of the core, aconventional method has been employed, namely to reduce the amount ofmolding material with poor moldability, or on the contrary to increasethe amount of molding material with high moldability. In other words,since the active medicine ingredients (effective ingredients or mainingredients) commonly possess poor moldability, there were only twoalternatives either to reduce the amount of effective ingredients of thecore, or to improve wear resistance by feeding large amount ofexcipients etc., to increase the weight of the core.

In case of the traditional compression-coated tablet, since more orless, offset in positioning of the fed core occurs, it was difficult toreduce the thickness of the outer layer, which was one of the reasonsfor the rather large size of a compression-coated tablet.

Similar problems with the moldability also exist in the field of theso-called conventional tablet, manufactured by compressing mixture ofeffective ingredients and excipients, etc. Since in most cases effectiveingredients are actually ingredients with poor moldability, under theexisting circumstances the methods to improve the moldability are, justlike in the above described case with the compression-coated tablet,only two either to decrease the ratio of addition of the effectiveingredients in the formulation, or to increase the ratio of addition ofexcipients, etc., for the improvement of the moldability, ignoring thefact that this will enlarge the size of the tablet.

Sill, there is another method to improve the moldability of someingredients with poor moldability by granulation, etc. However,considering the influence of the granulation solvent over the stabilityand the increase in costs due to increase in the number of themanufacturing process steps and also considering the fact that evenafter granulation the moldability of some ingredients do not improve,this method cannot be used as means for fundamentally modifying themoldability of all ingredients. Much more essential is the improvementachieved through modifying the composition of ingredients anddiminishing the concentration of effective ingredients.

Therefore, at present there are only two methods to improve themoldability of molding containing ingredients with poor moldabilityeither to decrease the ratio of ingredients with poor moldability whichoccupy in the formulation, or to feed large amount of ingredients thatimprove the moldability and thus increase total weight of products.

However, especially in pharmaceutics, the dosage of effectiveingredients is strictly fixed and therefore, in case that the effectiveingredients have poor moldability, the only two options are either todecrease the amount of those effective ingredients per tablet and toincrease the number of tablets to be taken, or, without increasing thenumber of tablets to be taken, just to enlarge the size of the tablets.This often caused problems with swallowing, especially among olderpeople and infants.

Next follows description of prior art for manufacture of a molding thatcontain granular molding material, which are highly brittle and lackingmoldability, such as microcapsules and various coated granule, used inpharmaceutics and food industry. However, description herein on suchgranular molding material will be limited to microcapsules.

In microcapsules, the granulated ingredients are protected from externalinfluences and therefore it can be expected that their stability willincrease and any possibility for undesired reaction with otheringredients in the same mixture will be eliminated. The solidificationof liquid active drug or low-melting-point active drug can be made to atablet, and they can also prevent oxidation reactions as well asphotolytic reactions, and combination alterations thereof and thusincrease the stability of the active drug compounds. Furthermore, theycan also control the reactions of the active drug in a living body. Forexample, when solution, made by dissolving of insoluble active drug intosolvent, is enclosed in capsules, its absorption efficiency in theliving body is improved. Or, by capsulation of one of the ingredients,susceptible to chemical reactions, it is isolated and allowed to enterchemical reactions only after being used. Furthermore, liquid productsare inconvenient to be utilized, therefore they are made into apparentlysolid particle or powder and thus by improving their weight and handlingproperties make them suitable for feeding into confectionery, cosmeticsand agricultural chemicals. In other words, the area of application ofgranulated molding material is indeed very wide.

The term “microcapsules” broadly includes besides the microcapsulesthemselves, also seamless capsules, mini soft capsules, micro spheres(micro beads) etc. The range of their utilization in pharmaceuticsdepends on their size, shape and characteristics. They can be used asmultiple-kinds of active drugs that are consumed at once, such asmultivitamins. Since there are special microcapsules such as sustainedrelease microcapsules and enteric-coated microcapsules, they can also befed to active drugs as controlled release preparations.

Up to now, when intended for oral administration, in most cases thosemicrocapsules were manufactured as capsule preparations, filled intohard capsules, due to their easy handling properties. This made themvery expensive as well as difficult to take. Not only this, but gelatincapsules, that enclosed microcapsules, were easy to be tempered andoften were infected with foreign bodies, which could cause unfortunateaccidents. For this reason many efforts were put to develop a methodthat would allow avoiding the use of gelatin capsules and enable turningthe microcapsules into tablets.

Thus, turning the microcapsules into tablets has some advantagesespecially in the fields of pharmaceutics and food industry. However themanufacturing method for tablets, containing microcapsules, which wasbased on the prior art, presented two major problems. The first one isthe decline in hardness and wear-resistant properties of tablets, due tolack of moldability in microcapsules themselves. The second one is theincrease in variation of the microcapsules' content in tablets, due toseparation or segregation of microcapsules and excipients duringtabletting process.

Tablets containing microcapsules is disclosed in Japanese PatentLaid-open Pub. Nos. Sho50-36619, Sho53-142520, Hei2-72113, Hei2-237914,Hei9-52847 and 2000-16932. In general, however, microcapsules arecoreless structures made of encapsulated in gelatin lipid-soluble orwater-soluble ingredients as active drug. For this reason, when highphysical pressure is applied from outside, the coating gets broken andthe active drug ingredients are released.

Next, the coating of the microcapsules is made of gelatin which is aningredient with poor moldability, and hence, when compared withexcipients, used in pharmaceutics and food industry, the microcapsulesare extremely poor in moldability. Such poor moldability is attributableto the poor plastic deformability of the microcapsules themselves. Onthe contrary, this characteristic makes it possible to maintain theshape of capsules even inside tablets.

Furthermore, shape of other capsules, such as seamless capsules andmicro-spheres, is smooth surfaced perfect sphere and, combined with thefact that the ingredient of the coating is gelatin, which has poormoldability at tabletting, it makes manufacturing of tablets as singleunits impossible.

Thus, when microcapsules, that completely lack moldability, are moldedtogether with excipients, in order to improve this lack of moldability,it is necessary to apply high tabletting pressure during tablettingprocess. However, the tabletting with a high pressure might lead to newproblems, such as breaking of the microcapsule coating. So at presentthe manufacturing process is stuck in a situation in which increasingpressure in order to improve moldability will cause breaking of themicrocapsule coating, and on the other hand decreasing pressure in orderto prevent destruction of the coating will result in insufficientmoldability.

In order to secure the moldability and prevent the destruction of thecoating due to increased compression stress upon tabletting, themicrocapsules are sandwiched between layers, formed by granulatedexcipients and a layer of excipients is used as a buffer-agent againstcompression during the tabletting process. This technique is disclosedin Japanese Patent laid-open Pub. No. Sho50-36619. In Japanese PatentLaid-open Pub. No. Sho53-142520 there is disclosed a description thatlactose, ordinary crystalline cellulose and starch in large amounts canbe used as excipients. Crystalline cellulose is described herein to beespecially effective as excipients. Furthermore, in Japanese PatentLaid-open Pub. No. Sho61-221115 is disclosed a method, employing about10 to 50% ordinary crystalline cellulose.

However, when manufacturing such tablets, there are two options eitherto decrease the microcapsules content by amount, i.e., the amount of theactive drug contained therein, or to feed large amount of excipients inorder to keep a predetermined amount of active drug or microcapsulescontaining the predetermined amount of the active drug. In other words,it is practically impossible to manufacture tablets with high content ofmicrocapsules. In case of medicines for example, the amount of theactive drug that must be contained in one tablet or one dosage dependson the efficacy of this active drug and therefore the amount of theactive drug cannot be reduced. As a result, the amount of the excipientsis increased and the tablets become intolerably large in size.

There is also a different method to achieve moldability by granulatingmicrocapsules with a binder and/or suitable excipients. Japanese PatentLaid-open Pub. No. Hei9-52847 discloses a tablet manufacturing method bywet mixing granulation. Another tablet manufacturing method usingsimilar techniques for wet mixing granulation is disclosed in JapanesePatent Laid-open Pub. No. 2000-16932. However, tablets that contain 28%microcapsules of this embodiment had 1% friability (in accordance withJapanese Pharmacopoeia) and not very good moldability. Furthermore, themixing granulation method, in which the granule is formed by high-speedrotation of blades and kneading, involves some problems such asdestruction of the microcapsules during granulation steps. Besides,gelatin, which is the main material for microcapsules, swells at contactwith water and so it would be difficult in terms of steps and qualitiesto use water as the granulation solvent. Therefore ethanol or otherorganic solvents should be used as granulation solvent, which leads tonew problems such as increase of the production costs and residualsolvent in the manufacturing environment and in the product itself.

Thus, it is very difficult to manufacture tablets that contain largeamount of microcapsules, using the traditional methods. The problem isnot only the moldability of the tablets, but also the dispersion ofmicrocapsule content in the tablet, caused by the dissociation orsegregation of the microcapsules and the excipients during the processof tablet forming.

In general, granulated bodies, containing large particles likemicrocapsules and small particles like excipients, differ in frictioncoefficient, depending on the size of the particles and the state oftheir surface. For this reason, due to movement and vibration of therotary table during the process of tablet formation, the granulatedbodies are often separated into large particles and small particles.Thus the granulated bodies are divided into a group of large sizeparticles and a group of small size particles (particle sizesegregation). Furthermore, since the microcapsules and the excipientsalso differ in density, it is easy to cause segregation due to densitydifference (density segregation).

Due to these two segregation factors, as the time for tablet formationelapses, the product also undergoes separation or segregation. As aresult, the separated or segregated tablet material is fed and molded ina die, so the amount of microcapsules in the tablets undergoes a change.There are two methods to prevent the separation or segregation describedabove. The first one is to granulate the microcapsules and theexcipients and make them one particle. The second one is to decrease thecontent of microcapsules and feed the tablet material into a die beforethe separation or segregation occurs. However, the first granulationmethod presents some problems such as problems of the above-describedsolvent and increase in the cost, as well as insufficient moldability.The second method also cannot provide a substantial solution to allproblems, as it just reduces the separation or segregation, but in doingso it makes impossible to prescribe large amounts of microcapsules.

In case of the traditional molding, containing microcapsules, themicrocapsules more or less come to the surface of the molding andproblems such as desorption of the microcapsules from the molding cannotbe avoided. Problems such as poor moldability and friability also remainunsolved.

DISCLOSURE OF THE INVENTION

As described above, the prior art for the manufacture of a molding withcore still holds some problems such as productivity problems, expenseproblems, occasional manufacturing of a molding without core or withplural cores, problems with centering of the core in the process ofsupplying of the core and with offset of the core due to the centrifugalforce of the rotary table, which furthermore cause molding disorders,restrained shape of a core, etc. The method that will solve all theseproblems at once is not to feed a solid core, molded in advance, but toform at once a molding with core from powder granule, used also as basicmolding material for the core. Therefore, the present invention presentsa method that allows molding at once the molding with core, or, in otherwords, a integral molding method, and an apparatus, necessary for it.

According to the present invention there is provided a method formanufacturing a molding with core, the method executed by use ofcompression molding means, the compression molding means comprising anupper punch and a lower punch which are arranged in the verticaldirection of a die, at least the upper punch having a double structureconsisting of a central punch and an outer punch surrounding the outerperiphery of the central punch, both the central punch and the outerpunch being capable of sliding motions as well as compressingoperations. Preferably, the lower punch also has such a doublestructure. The method is a method for manufacturing a molding with core,comprising supply steps of supplying molding material for core andmolding material for outer layer, respectively; a compression moldingstep of compression-molding the molding material for core and/or themolding material for outer layer; and a compression molding step ofcompression-molding the whole molding with core. More specifically, themethod comprises an outer layer supply step 1 of supplying moldingmaterial for outer layer, into a space above the lower central punchenclosed by the lower outer punch; a core supply step of supplyingmolding material for core, into a space above the molding material forouter layer supplied in the preceding step, enclosed by the lower outerpunch; an outer layer and core molding step of compression-molding themolding material for outer layer and the molding material for core,supplied in the precedent step; furthermore an outer layer supply step 2of supplying the molding material for outer layer, into a space in a dieabove and around the outer layer and a core molding formed in theprecedent step; and a whole molding step of compression-molding theouter layer and the core molding and the molding material for outerlayer.

In the present invention, an apparatus for execution of the above methodcan be an apparatus for manufacturing moldings with core, the apparatusbeing in the form of a rotary compression molding machine having arotary table which is able to rotate, the rotary table being providedwith a die having a die opening, the apparatus having an upper punch anda lower punch which are supported vertically slidably in the verticaldirection of the die, the upper punch and the lower punch being movedtoward and pressed against each other with the tips of the punchesinserted in the die, to thereby perform compressing operations on themolding material filled in the die, wherein at least the upper punch,preferably with the lower punch, has a double structure consisting of acentral punch and an outer punch surrounding the outer periphery of thecentral punch, both the central punch and the outer punch being capableof sliding motions and compressing operations to make up a double punch,and wherein the apparatus comprises means for moving the central punchand the outer punch of the double punch, and means for enabling thecompressing operations of the central punch and the outer punch, andwherein the rotary table includes thereon supply sites for moldingmaterial for core and molding material for outer layer, respectively, acompression molding site for the molding material for core and/or themolding material for outer layer, and a compression molding site for thewhole molding with core. In other words, the present manufacturingapparatus is a rotary compression molding machine, constructed so as tobe able to execute a series of steps of the method for manufacturingmoldings with core of the present invention. This rotary compressionmolding machine is easily applicable to manufacture of moldings havingplural cores which will be described later.

The present invention also relates to a molding with core, manufacturedby the method or apparatus for manufacturing a molding with core of thepresent invention. The method for manufacturing a molding with core inaccordance with the present invention made it possible, when usingmolding an ingredient with poor moldability, to manufacture a moldingwith high moldability and high wear resistance without decreasing theamount of the molding material in question and without increasing thesize of the finished product. In other words, in the molding with core,manufactured by the method and apparatus of the present invention,molding material with superior moldability are used only or mostly inthe compression cover layer, which is an outer layer, while moldingmaterial with poor moldability is used mainly in the core and thus theinvention succeeded in making smaller in size a molding by decreasingthe loadings of excipients and at the same time in improvingconsiderably the moldability and the friability of the molding. Besides,this integral molding method does prevent offset in the positioning ofthe core and therefore it becomes possible to make the outer layerextremely thin, which also contributes to making the molding smaller insize.

Thus, the molding with core of the present invention have both a coreand an outer layer, surrounding the core, which are integrally molded.One aspect provides a molding with core having a core made of anincomplete molding. Another aspect provides a molding with core havingan outer layer whose thickness is small and in all its parts is 1 mm orbelow.

The present invention also relates to provision of a molding with corehaving plural cores. Beside the many problems, occurring at themanufacturing of a molding having a single core, the manufacturing of amolding having plural cores faced some new problems, such as increasedfrequency of occurrence of a molding with plural cores or without core,problems of securing unified position of the plural cores, increase insize of the finished molding, etc., all of which are attributable to themanufacturing of a molding with plural cores and oddly shaped a moldingwith plural cores. The present invention solved at once all theseproblems and made it possible to provide a molding having plural cores,available in practice, a method for manufacturing the same, and anapparatus used for the execution of the method. In other words, in themethod described as the specific preferred method for manufacturing amolding with core, after the core supply step of supplying moldingmaterial for core, the molding material for the core or the outer layeris fed in the space enclosed by the lower outer punch and above thepreviously supplied molding material. Thus, by repeating more than oncethe step of supplying the molding material for the core or outer layer,a molding having plural cores can be easily manufactured.

The molding having plural cores, manufactured by the method or apparatusfor manufacturing the molding with plural cores include plural coreswhich are distributed vertically with respect to the pressurizationsurface of the molding. Besides, the method and apparatus formanufacturing a molding having plural cores enable a smooth and fastmanufacturing of moldings having plural cores, distributed in specificposition. In other words, they provide an aggregate of moldings havingplural cores, which is distributed in specific position.

The present invention also relates to a molding with core, containing inthe core microcapsular granule (which will be detailed later) such asmicrocapsules or coated granule that are clusters of particles, whichhave poor moldability and high brittleness and loose theircharacteristics, features and functions when destroyed.

In manufacturing a molding with core, containing large amounts ofmicrocapsular granule, it was difficult to secure uniformity of contentby amount and prevent increase in size of the finished molding. In themethod for manufacturing a molding with core and especially in themethod for manufacturing a molding having plural cores of the presentinvention, a molding was devised that have a structure to apply themicrocapsular granule as molding material for core and in that space toinsert molding material with superb moldability (ingredients for outerlayer). In other words, the method for manufacturing a molding with coreof the present invention enables manufacturing of a molding, containinglarge amounts of microcapsullar granule, which amounts are standardized.The molding in question can prevent increase in size as much aspossible, so as to be of size suitable for practical applications.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an explanatory diagram of the step of a punch tip, showing afirst example of a method for the manufacture of a molding with core ofthe present invention (slanted lines as section are omitted);

FIG. 2 is an explanatory diagram of the step of the punch tip, showing amethod for the manufacture of a molding having plural cores of thepresent invention (slanted lines as section are omitted);

FIG. 3 is an explanatory diagram of the step of the punch tip, showing asecond example of the method for the manufacture of a molding with coreof the present invention (slanted lines as section are omitted);

FIG. 4 is an explanatory diagram of the step of the punch tip, showing athird example of the method for the manufacture of a molding with coreof the present invention (slanted lines as section are omitted);

FIG. 5 is an explanatory diagram of the step of the punch tip, showing apartly altered model of the third example of the method for themanufacture of a molding with core of the present invention (slantedlines as section are omitted);

FIG. 6 shows an example of an upper punch of a punch having a doublestructure for use in the present invention, (A) being a verticalsectional view (right half) as well as a diagrammatic view (left half),(B) being a side view, which punch corresponds to a double punch of FIG.10;

FIG. 7 shows, in longitudinal section (right half) and in diagrammaticview (left half), an example of an upper punch of the punch having adouble structure for use in the present invention, which punchcorresponds to a double punch of FIG. 11;

FIG. 8 is an overall regular cross section of an ordinary rotarycompression molding machine, in which a punch, a standing shaft and ahopper are not shown as section;

FIG. 9 is a diagrammatic top plan view of a rotary table in an aspect ofa rotary compression molding machine of the present invention;

FIG. 10 is a regular cross section of the rotary table of the rotarycompression molding machine of the present invention, showing the stepmechanism of upper and lower punches in development, in which an aspectof the apparatus of the present invention is shown, with slanted linesas section omitted;

FIG. 11 is a regular cross section of the rotary table of the rotarycompression molding machine of the present invention, showing the stepmechanism of the upper and lower punches in development, in which anaspect of the apparatus of the present invention is shown and in whichthe step modes of the outer and central punches are reversed, withslanted lines as section omitted;

FIG. 12 shows a granular residue removal device of the presentinvention, with (A) being an overall view of the device and (B) being atop plan view thereof;

FIG. 13 shows a morphology of molding, manufactured by the method andapparatus for manufacturing a molding with core of the presentinvention, with (A) being a side view thereof, (B) being a top plan viewthereof, and (C) being a perspective longitudinal section thereof; and

FIG. 14 shows a morphology of a molding having plural cores of thepresent invention, with (A) being a longitudinal section (right half) aswell as a side view (left side), (B) being a top plan view, and (C)being a perspective longitudinal section.

Main reference numerals in diagrams are as follows: 1: rotary table, 3:die, 4A, 83B: upper central punch, 4B, 83A: upper outer punch, 5A: lowercentral punch, 5B: lower outer punch, 21, 22: granular residue removalunit, 30, 31, 32, 33: reduction device, 35: rail of lower central punch,36: rail of lower outer punch, 37: bottom of central punch, 41, 42, 43:descent cam of upper central punch, 44,46: upper temporary compressionroller, 45, 47: bottom temporary compression roller, 48: preliminarycompression roller for upper central punch, 49: preliminary compressionroller for lower central punch, 50: main compression roller for uppercentral punch, 51: main compression roller for lower central punch, 52:rail of upper central punch, 53, 54, 55: descent cam for upper outerpunch, 56: rail of upper outer punch, 57 (57A, 57B): granular residue,62, 63: ascent cam, 65, 66: force rail, 67: preliminary compressionroller for upper outer punch, 68: preliminary compression roller forlower outer punch, 69: main compression roller for upper outer punch,70: main compression roller for lower outer punch, 73: control rollerfor vertical sliding motion of lower outer punch, 74: control roller forvertical sliding motion of upper outer punch, 78, 80: compression bedfor outer punch, 79,81: compression bed for central punch, 82: controlroller for vertical sliding motion of central punch, NP: core, OP1:first outer layer, OP2: second outer layer.

BEST MODE FOR CARRYING OUT THE INVENTION

In this description, the term “molding material” refer to both wet anddry powder granule or other material that can be molded, and the term“powder granule” includes all powder, granule and similar substance.

In a manufacturing method of a molding with core of the presentinvention and a manufacturing apparatus of moldings with core, themolding material is preferably powder granule.

The method for the manufacture of a molding with core of the presentinvention is a method for manufacturing a molding with core, the methodexecuted by use of compression molding means, the compression moldingmeans comprising an upper punch and a lower punch which are arranged inthe vertical direction of a die, at least the upper punch having adouble structure consisting of a central punch and an outer punchsurrounding the outer periphery of the central punch, both the centralpunch and the outer punch being capable of sliding motions as well ascompressing operations. Usually the lower punch is also a punch having adouble structure a central punch and an outer punch, surrounding theouter periphery of the central punch, both the central punch and theouter punch being capable of sliding motions and pressurization steps.Detailed description on the double structure punche follows in the partof the apparatus for the manufacture of moldings with core of thepresent invention.

The method for the manufacture of a molding with core of the presentinvention includes supply steps of supplying molding material for coreand molding material for outer layer, respectively; a compressionmolding step of compression-molding the molding material for core and/orthe molding material for outer layer; and a compression molding step ofcompression-molding the whole molding with core. Preferably thecompression molding step of molding material for a core and/or moldingmaterial for an outer layer is a temporary compression. Usually the stepof supplying the molding material for an outer layer is preformed morethan twice.

In such case, depending on the shape of the punch tip, it is necessaryor preferable to perform the step of removing of granular residue fromthe lower outer punch. This will be described in detail later.

A preferred aspect of the method for the manufacture of a molding withcore of the present invention is expressed as a method comprising anouter layer supply step 1 of supplying molding material for outer layer,into a space above the lower central punch enclosed by the lower outerpunch; a core supply step of supplying molding material for core, into aspace above the molding material for outer layer supplied in thepreceding step, enclosed by the lower outer punch; an outer layer andcore molding step of compression-molding the molding material for outerlayer and the molding material for core, supplied in the precedent step;furthermore an outer layer supply step 2 of supplying the moldingmaterial for outer layer, into a space in a die above and around theouter layer and core molding formed in the precedent step; and a wholemolding step of compression-molding the outer layer and core molding andthe molding material for outer layer. The above method is implemented byusing compression molding means comprising an upper punch and a lowerpunch, both the upper and lower punch having a double structureconsisting of a central punch and an outer punch surrounding the outerperiphery of the central punch, both the central punch and the outerpunch being capable of sliding motions as well as compressingoperations. This method is basically a method for the manufacture of amolding with core, consisting of the steps described above, but ifnecessary other steps may be added thereto.

In this method for the manufacture of a molding with core according tothe above aspect, when ordinary powder granule is used as moldingmaterial, in order to prevent contamination of the powder granule of theouter layer and the powder granule of the core and to make cleardistinction between the outer layer part and the core part, it ispreferable to perform the outer layer molding step in which the moldingmaterial for the outer layer is compression-molded, immediately afterthe outer layer supplying step 1.

In this method for the manufacture of a molding with core according tothe aspect, it is also preferable in the outer layer and core moldingstep and the outer layer molding step which will be preferably carriedout, the compression operation is performed as temporary compression.The molding with core, manufactured in this step is called a temporarymolding with core and are included in the group of a molding with core.Also, the compression during the overall molding step could be only maincompression, but it is desirable to perform the main compression afterpreliminary compression (temporary compression). Thus, performing oftemporary compression improves the unity of the finished molding andalso enables miniaturization of the finished molding with core.

The present invention also relates to the method for the manufacture ofa molding having plural cores. By repeating some of the steps of themethod for the manufacture of a molding with core according to theaspect, it becomes possible to manufacture easily a molding havingplural cores. In other words, by executing an outer layer/core repeatedsupply step, posterior to the core supply step of supplying the moldingmaterial for core, it becomes possible to manufacture easily a moldinghaving plural cores. The outer layer/core repeated supply step includesa core or outer layer supply step repeated more than once, the core orouter layer supply step including supplying the molding material forcore or the molding material for outer layer, into a space above themolding materials supplied in the precedent steps, enclosed by the lowerouter punch. It is possible to choose whether to feed the moldingmaterial for the outer layer or the molding material for the coredepending on the need; if, as the outer layer/core repeated supply step,molding material for core is fed, it is possible to manufacture amolding with plural cores, in which two cores are contiguous; also if,as the outer layer/core repeated supply step, molding material for outerlayer and molding material for core are fed in the mentioned order, itis possible to manufacture a molding with plural cores, in which twocores are separated by an outer layer. If this step is repeated severaltimes, it becomes possible to manufacture easily a molding with pluralcores. Also, in the method for the manufacture of a molding with pluralcores of the present invention, when ordinary powder granule is used asmolding material, it is preferable to perform the compression moldingstep every time molding material is fed.

A first example of the optimal aspect of the method for the manufactureof moldings with core of the present invention will be described indetail hereinafter, with reference to FIG. 1. Herein, the compressionoperation in mid-course is a temporary compression, and the temporarycompression operation of molding material for the first outer layer OP1is performed without omission. Also the expressions such as the moldingmaterial for the first outer layer OP1 and the molding material for thesecond outer layer OP2 are used not to denote different molding materialbut as a convenient way to distinguish the different parts.

First, as the lower central punch 5A (FIG. 1A) is kept in its loweredposition, in the space for the first outer layer 201A, above the lowercentral punch 5A, which is enclosed by the lower outer punch 5B, themolding material for the first outer layer OP1 is supplied (FIG. 1B); ifnecessary the lower central punch 5A is raised and after the left-overof the molding material for the first outer layer is discharged out ofthe die, the upper central punch 4A and the lower central punch 5A movetowards each other to perform temporary compression (FIG. 1C) andtemporary molding of the first outer layer. (Outer layer molding step)

Next, as the temporary moldings of the first outer layer OP1 is held bythe lower central punch (5A) and the lower outer punch (5B), ifnecessary the lower central layer 5A is lowered and in the space 202Afor core above the first outer layer OP1 temporary moldings, which isenclosed by the lower outer punch 5B, the molding material for core NPis supplied (FIG. 1E, F). Then, if necessary the lower central punch 5Ais raised, and after the left-over of the molding material for core isdischarged out of the die, the upper central punch 4A and the lowercentral punch 5A move towards each other, to perform temporarycompression (FIG. 1G) and temporary molding of the first outer layer andthe core. (Outer layer and core molding step)

As the temporary moldings of the first outer layer and the core are heldby the lower central punch 5A and the lower outer punch 5B, the lowerpunch (both the lower central punch 5A and the lower outer punch 5B orthe lower outer punch 5B alone) is lowered (FIG. 1I), in the die 3 inthe space for the second outer layer 203A, which is above the temporarymoldings of the first outer layer and the core and around them, themolding material for the second outer layer OP2 is supplied (FIG. 1J,1K). The temporary moldings of the core, which are kept over the firstouter layer temporary moldings, is enclosed completely in the moldingmaterial for the outer layer and the outer layer temporary moldings(FIG. 1K) and if necessary the left-over of the molding material for thesecond outer layer OP2 is discharged out of the die 3 (FIG. 1L).However, here the molding material for the second outer layer OP2 can befed after the lower outer punch 5B is sufficiently lowered beforehandand the temporary molding of the first outer layer and the core arepushed up. After that the upper punch (the upper central punch 4A andthe outer central punch 4B) and the lower punch (the lower central punch5A and the lower outer punch 5B) move towards each other and, ifnecessary, perform preliminary compression (temporary compression) ofthe whole moldings, which consists of the first outer layer, the coreand the second outer layer, after which perform final main compression(FIG. 1M). (Overall molding step)

FIG. 1N shows the step of taking out the finished moldings.

The tip of the outer punch (6B, 7B) corresponds to the edge 76 on thecircumference of the finished molding, shown in FIG. 13 and depending onthe shape of the molding it could be flat, but in cases when it is notflat, as shown in FIG. 1, in order to prevent contamination of themolding material for outer layer and the molding material for core, itis preferable to feed an removal step (FIG. 1D,H) of the moldingmaterial residue 57 (57A, 57B) from the surface of the lower outer punch7B after supplying the first outer layer OP1 or during or after thecompression molding (temporary molding) of these molding material, aswell as after supplying the core NP or during or after the compressionmolding (temporary molding) of the first outer layer OP1 and the coreNP. This removal step can be performed by shooting and suction ofcompressed air (the device in FIG. 12) or by brushing, scraper orcombination of the above. They are called means for removal of moldingmaterial residue.

In the method described above, by performing, after the step of moldingof outer layer and core, of the outer layer/core repeated molding step(supply and molding step) performing more than once of the steps offeeding of the molding material for outer layer or the molding materialfor core and of the compression molding, moldings with plural cores canbe easily manufactured. FIG. 2 shows a molding having plural cores,divided by the outer layer, where the first repetition of the above stepsupplies the molding material for outer layer (for the second outerlayer OP2) and the second repetition supplies the molding material forthe core (second core NP2). If the supplying of the molding material forcore in this step is done just once, the two cores will exist in chain.Besides, FIG. 2 is an example of the case when the tip of the lowerouter layer has flat construction and means for removal of moldingmaterial residue is not necessary.

As far as the method for the manufacture of moldings having plural coresin the present invention is concerned, the entire step, without skippingthe steps of feeding and compression molding each ingredient, can beeasily explained as follows.

As the lower central punch is kept in lowered position, in the space forthe first outer layer, enclosed by the lower outer punch and above thelower central punch, the molding material for outer layer is suppliedand, if necessary, the left-over of the molding material for the firstouter layer is discharged out of the die; then the upper central punchand the lower central punch move towards each other and performcompression, thus performing the step of molding of the outer layermolding of the first outer layer. Next, as the lower central punch iskept in lowered position, in the space for the core above the moldedfirst outer punch, enclosed by the lower outer punch, the moldingmaterial for core is supplied and, if necessary, the left-over of themolding material for core is discharged out of the die; then the uppercentral punch and the lower central punch move towards each other andperform compression, thus performing the step of molding of the outerlayer and the core molding of the first outer layer and the core. In thesame way, as the lower central punch is kept in lowered position, in thespace enclosed by the lower outer punch and above the outer layer andthe moldings with core, molded in the previous steps, the moldingmaterial for outer layer and the molding material for core are fed and,if necessary, the left-over of the molding material is discharged out ofthe die; then the upper central punch and the lower central punch movetowards each other and perform compression, thus performing more thanonce the outer layer/core repeated molding step molding of the core andthe outer layer. Then, as the lower punch is kept in lowered position,above the outer layer and moldings with core and in the space for thefinal outer layer and around it the molding material for the final outerlayer is fed, the moldings with core are completely enclosed in themolding material for outer layer and the outer layer moldings and, ifnecessary, the left-over of the molding material for final outer layeris discharged out of the die; then the upper punch and the lower punchmove towards each other and perform compression, thus performing thestep of overall molding.

The present invention method for manufacturing a molding having pluralcores can be applied for the manufacture of a molding that containmicrocapsules and coated granule, in other words, microcapsule typeparticles (definition will be given later on). In other words, themicrocapsule type particles are used as molding material for core and byusing molding material for outer layer in the first repetition of theouter layer/core repeated molding step and microcapsule type particlesas molding material for the core in the second repetition of the outerlayer/core repeated molding step, the manufacturing of a molding thatcontain microcapsule type particles can be achieved.

However, when microcapsule type particles are used as molding materialfor core, necessity to perform compression molding upon feeding of eachingredient is low and at the stages of initial supplying of moldingmaterial for outer layer, of initial supplying of microcapsule typeparticles as well as of second supplying of molding material for outerlayer step of compressing makes it even easier for the molding materialfor outer layer and the microcapsule type particles to mix together andthat is why it is preferable to perform temporary compression so that tolevel the surface.

Incidentally, when the content of microcapsule type particles is low, itis possible to perform the step of supplying of microcapsule typeparticles just once and skip the process of feeding of outer layer. Inother words, in this case even if ingredients with superb moldabilityare not inserted in the microcapsule type particles in the core, themolding can achieve sufficient moldability and wear resistance.

Next, referring mainly to FIG. 3, detailed description will be made of asecond example of the method for the manufacture of moldings with coreof the present invention. Here the temporary compression is used ashalfway compression. However in this method temporary compressionoperation of the molding material for first outer layer OP1 cannot beskipped. In exchange, skipping of the temporary compression of themolding material for core NP is possible.

As the lower punch (the lower central punch 5A as well as the lowerouter punch 5B) is kept in lowered position (FIG. 3A), the space 201Bfor first outer layer above the lower punch is filled with the moldingmaterial for the first outer layer OP1, if necessary the lower centralpunch 5A or the lower central punch 5A and the lower outer punch 5B areraised up to a fixed position (FIG. 3B) and the left-over of the moldingmaterial for the first outer layer OP1 that has overflowed in the die 3is discharged. Then the upper punch (the upper central punch 4A as wellas the upper outer punch 4B), which is pushed the upper central punch 4Aagainst the side of the lower central punch 5A, and the lower punch (thelower central punch 5A as well as the lower outer punch 5B) move towardseach other and by producing compression perform temporary molding ofpot-shaped first outer layer (FIG. 3C).

Next, in the space for core 202B inside the temporary moldings of thepot-shaped first outer layer, the molding material for core NP issupplied (FIG. 3E) and, if necessary, the left-over of the moldingmaterial for core is discharged. Then, by moving the upper central punchtowards the lower punch, the molding material for core NP is subjectedto temporary compression and the core NP or the core NP and the firstouter layer OP1 are temporarily molded (FIG. 3F).

Then, as the temporary moldings of the first outer layer OP1 and thecore NP are supported by the lower punch, if necessary the lower punchis lowered, the molding material for second outer layer is supplied inthe space for the second outer layer 203B, which is above the temporarymoldings of the first outer layer OP1 and the core NP (FIG. 3H) andthen, if necessary, the lower punch is raised up to a fixed position andthe left-over of the molding material for the second outer layer OP2 isdischarged out of the die 3. Then the upper punch and the lower punchmove towards each other, to perform, if necessary, preliminarycompression (temporary compression) of the whole moldings, made of thefirst outer layer, the core and the second outer layer, and finally maincompression (FIG. 3I). FIG. 3J shows the step of taking out of thefinished moldings.

Furthermore, this method can be applied even if the lower punch is anordinary punch and not with a double structure. In this case, as shownin FIG. 3B, since the lower central punch cannot be pushed up, there aresome minor problems with filling of the molding material and in order tocreate hollow parts in the flatly filled molding material, usingpushed-up upper central punch, in some cases the filling of the moldingmaterial on sides is not sufficient. However, when the cores are insmall amount, the method can be applied without problems.

In this second example of the method for the manufacture of moldingswith core, in order to prevent contamination of the outer layer from themolding material for the core NP, it is preferable, after supplying ofthe molding material for the core NP or during or after the compressionmolding (temporary molding) of the core NP (or the core and the firstouter layer), to feed an removal step of the residue of molding materialfor the core 57B, that has stuck on the upper part of the temporarymoldings of the first outer layer OP1 at supplying of the moldingmaterial for the core NP (FIG. 3F). Furthermore, in FIG. 3F bothtemporary compression operation and the removal step of the moldingmaterial residue are performed simultaneously. This removal step followsthe first example of the present manufacturing method.

Next, the third example of this method for the manufacture of moldingswith core of the present invention will be explained below, based mainlyin FIG. 4. In this method also the temporary compression is used as ahalfway compression operation. Furthermore, in this method it isimpossible to skip temporary compression operation of the moldingmaterial for core NP. The step of compression of the molding materialfor first outer layer OP1 is optional.

The lower punch (the lower central punch 5A as well as the lower outerpunch 5B) is kept in lowered position (FIG. 4A), the molding materialfor core NP is filled in the space above the lower punch of the die and,if necessary, the lower punch is raised up to a fixed position and theleft-over of the molding material for core NP that has overflowed in thedie 3 is discharged (FIG. 4B). The upper punch (the upper central punchas well as the upper outer punch 4B) is lowered and inserted in the die;the molding material for core NP is kept in the space among the upperpunch, the lower punch and the die (FIG. 4C); the upper outer punch 4Bis pushed in the direction of the lower outer punch 5B or the uppercentral punch 4A is pulled in or both steps are performed and the spacefor core 202C, enclosed by the upper central punch 4A and upper outerpunch 4B, is formed (FIG. 4D); in this space the molding material forcore NP is filled by pushing up the lower central punch 5A (FIG. 4E).Then the lower central punch 5A is pushed up into the upper centralpunch 4A, the upper central punch 4A and the lower central punch 5A movetowards each other and produce compression temporarily and thus in thespace enclosed by the upper outer punch 4B and under the upper centralpunch 4A the step of temporary molding of core is performed (FIG. 4F).After that, as the temporary moldings with core is kept on the uppercentral punch 4A and the upper outer punch 4B, the upper punch is pulledout of the die (FIG. 4G) and at the same time the lower punch is raisedagainst the upper punch and the left-over of the molding material forcore NP is discharged (FIG. 4H, 4I).

Next, in the space for the first outer layer 201C above the lower punchin the die (FIG. 4K), the molding material for first outer layer OP1 issupplied (FIG. 4K) and, if necessary, the left-over of the moldingmaterial for first outer layer OP1 is discharged. Then, the lower punch,holding the molding material for first outer layer OP1, is lowered (FIG.4L), at the same time the upper central punch 4A and the upper outerpunch 4B, holding the molding material for core, are lowered and theupper punch is inserted in the die (FIG. 4M). By pushing out the uppercentral punch 4A in downward direction, the molding material for core isreleased over the molding material for first outer layer OP1 (FIG. 4N,4O). The molding material for second outer layer OP2 is filled (FIG. 4P)above the core temporary moldings as well as in the space for themolding material for second outer layer 203 C around the core temporarymoldings (FIG. 4O) and, if necessary, the lower punch is raised up to afixed position and the left-over of the molding material for secondouter layer OP2 is discharged out of the die. After that the upper punchand the lower punch move towards each other and the whole moldings, madeof the core, the first outer layer and the second outer layer, issubjected first, if necessary, to a preliminary compression (temporarycompression) (FIG. 4Q) and then to a final main compression (FIG. 4R).FIG. 4T shows the step of taking out of the finished moldings.

Furthermore, in the third example for the method for manufacturing ofmoldings with core of the present invention, as shown in FIG. 5, it isalso possible to fill the molding material for core NP in the spaceabove the lower central punch 5A and enclosed by the lower outer punch5B, then lower the upper punch (the upper central punch 4A as well asthe upper outer punch 4B) and move the molding material for core NP frominside the lower outer punch 5B into the upper outer punch 4B.

This method for the manufacture of a molding with core of the presentinvention can be executed, using the following system: the die has anupper and a lower punches and at least the upper punch, but preferablyboth the upper and lower punch have double structure, consisting of acentral punch and an outer punch that surrounds the outer periphery ofthe central punch; those central punch and outer punch can perform bothsliding and molding steps. Usually, the lower punch, just like the upperpunch, has double structure, but as described above in the secondexample, this method can be executed using ordinary punches too.

Further on in the present invention the rotary compression moldingmachine is said to be compression molding means, but in general if thereare an upper punch, a lower punch and a die, where at least the upperpunch has a double structure made up by a central punch and an outerpunch that surrounds the outer periphery of the central punch, thismethod can be executed easily using a hydraulic press. In other words,following the order of steps in the present invention, either the upperand the lower punch or the central and the outer punch are movedmanually and/or automatically to a fixed position and after the moldingmaterial (molding material for outer layer, molding material for core)is filled, by using a hydraulic press for a series of steps andfollowing the order of steps in the present invention so that to applypressure form vertically, this method can be easily executed.Furthermore, usually both the lower punch and the upper punch, used inthis method, have a double structure. About punches with doublestructure refers to following explanations as well as FIGS. 6 and 7.

The present invention's method for the manufacture of moldings with corecan be executed using the manufacturing apparatus of the presentinvention, given below.

The present invention's apparatus for the manufacture of moldings withcore keeps the generally used traditional rotary compression moldingmachine, or in other words, the rotary table and it employs a mechanismof rotary molding compression machine where on the plate is set a diewith an opening and on the bottom and the top of the die there arebottom and upper punch that can move in both directions and can performsliding motion; by moving the upper and the lower punch towards eachother and pressing the tips of the punches inserted inside the die, thestep of compressing of the powder granule inside the die is performed.This apparatus is also constructed so that to be able to perform theseries of steps in the present invention method for the manufacture ofmoldings with core at least the upper punch has a double structure madeof a central punch and an outer punch that surrounds the outer peripheryof this central punch; in this double structure both the central punchand the outer punch can perform sliding motions as well as compressingoperations; the apparatus has means to move the central punch and theouter punch of this double structure and also means to enable thecompressing step of the central punch and the outer punch.

In other words, the characteristics of the present invention apparatusfor the manufacture of moldings with core are as follows: a rotarycompression molding machine device, consisting of a rotary table and adie with an opening on this rotary table, in which there are an upperpunch and a lower punch that can move in both directions and can performsliding motions, performs a compressing step on the molding material,filled in the die, by moving the upper punch and the lower punch towardseach other and inserting the tips of the punches in the die; in thisrotary compression molding machine at least the upper punch has a doublestructure made up of a central punch and an outer punch surrounding theouter periphery of this central punch; both the central punch and theouter punch can perform sliding motions as well as compressingoperations; the apparatus has means to move the central punch and theouter punch as well as to enable compressing operations of the centralpunch and the outer punch; on the same rotary table there are a sectionfor supplying of the molding material for core and the molding materialfor outer layer, a section for compression molding of the moldingmaterial for core and/or the molding material for outer layer and asection for compression molding of the whole moldings with core. In thisapparatus usually the section for supplying the molding material forouter layer exists on more than two places.

Furthermore, in the present invention apparatus for the manufacture ofmoldings with core, usually even the lower punch has a double structure,made up of a central punch and an outer punch surrounding the outerperiphery of this central punch; both the central punch and the outerpunch in this double structure can perform sliding motions as well ascompressing operations; the apparatus has means to move the centralpunch and the outer punch of this double structure as well as to enablecompressing operations of the central punch and the outer punch.

Also, usually in the rotary compression molding machine, powder granuleis used as molding material and in this case sometimes the apparatus hasa device for removing the powder granule residue, left on the lowerouter punch or on the molding, due to the shape of the punch tip.

Preferable form of the present invention apparatus for the manufactureof moldings with core is a rotary compression molding machine with thefollowing characteristics: both the upper and the lower punch havedouble structure, made of a central punch and an outer punch thatsurrounds the outer periphery of the central punch; both the centralpunch and the outer punch can perform sliding motions as well ascompressing operations; the apparatus has means to move the centralpunch and the outer punch of the double structure as well as means toenable compressing operations of the central punch and the outer punch;the apparatus has a section for first supplying of molding material inthe space enclosed by the outer punch, a section for first compressionmolding of the molding material, using the upper central punch and thelower central punch, a section for second supplying of molding materialin the space enclosed by the outer punch, a section for secondcompression molding of the molding material, using the upper centralpunch and the lower central punch, a section for supplying in the spaceinside the die of the final molding material and a section forcompression molding of the whole moldings, using the upper and the lowercentral and outer punch.

In order to provide more detailed explanation of the present inventionapparatus for the manufacture of moldings with core, first thetraditional rotary compression molding machine will be explained.

The rotary compression molding machine, as shown in FIG. 8, if forexample is a shaft-operated device, is constructed as follows: in thecentral part of the main frame 111 a standing shaft 101 is placed,supported by a bearing 100; the revolving operating power is transmittedto the shaft by a motor 102 and near the shaft a rotary table 103,divided into two functional parts, is fixed. Furthermore, in order topress the rotary table from up and bottom, above and under the rotarytable respectively a holding section for an upper punch 104, enablingvertical sliding motion of the upper punch and a holding section for thelower punch 105, enabling vertical sliding motion of the lower punch areset. On the rotary table 103 multiple die units with same circumferenceas the die opening 106 in order to correspond to ability of the die 114to be attached and removed are set. In the holding section for upperpunch 104 and the holding section for the lower punch 105, punch-holdingopenings 107, supporting sliding motions of the upper punch and thelower punch, are drilled. In this rotary table, in order to distributethe lower punch 108, the upper punch 109 and the die 114 so that theircenterlines coincide, a punch holder opening 107 and a die opening 106respectively are drilled. A rail 110 is set so as to correspond to partswhere trajectories of the upper punch 109 and the lower punch 108 touch;this rail is constructed so as to connect with each cam and to movevertically. In the die 114, the opening 113 goes all the way through, inorder to insert the tips of the upper punch 109 and the lower punch 108.Furthermore, in FIG. 8 reference numerals 112 and 115 denote acompression roller and a hopper, respectively.

There are also rotary compression molding machines, where the revolvingoperating power is supplied not by a shaft, but by a gear on a rotarytable. They could be external gear operated (external gear type) andinternal gear operated (internal gear type).

Next follows an explanation of the punches with double structure and theparts, attached to them.

The two-layer punch, used in the present invention, consists of acentral punch and an outer punch that surrounds the outer periphery ofthis central punch, where the outward form of the outer punch is almostthe same as the inside form of die and the outward form of the centralpunch is almost the same as the outward form of the core and the insideform of the outer punch. Furthermore, both the central punch and theouter punch can perform sliding motions as well as compressingoperations. When the sliding part that connects both punches is removed,basically the central punch and the outer punch can perform slidingmotions separately.

One example is a punch, corresponding to FIG. 10, which has constructionas shown in FIG. 6 a central punch 4A, an outer punch 4B, an outer punchcompressing bed 78, a central punch compressing bed 79 and a controlroller for vertical sliding motion of the outer punch 74. In thecompressing step, compression of the central part of tablets with largecompressing area is performed by pressing of the central punchcompressing bed 79 into the compression roller (44, 46, 48, 50 in FIG.10) and compression of the outer part of tablets is performed bypressing of the outer punch compression bed 78 into the compression roll(67, 69 in FIG. 10). Thus compression operations of the central punchand the outer punch are enabled.

Furthermore, the vertical sliding motion of the central punch iscontrolled according to the usual method by the rail of the centralpunch and the central punch bottom part 37 (identical to the centralpunch compression bed 79), but in order to enable the vertical slidingmotion of the outer punch, a vertical sliding motion control roller 74,directly touching the outer punch rail, is set. Preferably in thisroller multiple bearings 77 are placed, so that the roller could rotateand enable smooth vertical sliding motion of the outer punch.

Here, by placing the vertical sliding motion control roller 74 on theouter side of the outer layer compressing bed 78 and separating thevertical sliding motion control roller 74 from the outer layercompressing bed 78, during pressurization compression the rollerpressurizes only in the outer layer compressing bed 78 and does notapply direct pressurization on the vertical sliding motion controlroller 74 so that the bearings 77 inside the vertical sliding motioncontrol roller 74 are protected from damage. In the compressionoperation, even stronger pressurization can be applied on the side ofthe central punch towards the outer punch and thus it is possible totransmit effectively pressure from the compression roll to the moldingmaterial.

Furthermore, by separating vertically the central punch and thecompression roller contact part of the outer punch (the outer punchcompression bed 78 and the central punch compression bed 79)interference between compression rollers for the central punch and forthe outer punch is prevented.

FIG. 6 shows the upper punch, but the same is true for the lower punchalso, when a punch with double structure is used. When the lower punchis also with double structure, its differences from the upper punch areas follows: the tip of the lower punch that is inserted in the die islonger and in order to differentiate movements of the upper and thelower punches, parts that regulate movements of the punch (a spaceinside a die, etc) are different.

Another two-layer punch that can be used in the present invention, asshown in FIG. 11, is a punch that controls the movement of the centraland the outer punches in reverse. In other words, this punch controlsthe movement of the central punch by a vertical sliding motion controlroller and a rail and the movement of the outer punch by a punch bottompart (the same part as the outer punch compression bed 80) and a rail.This punch is also characterized, as shown in FIG. 7, by an opening inthe outer punch (outer punch opening section 85), from which the centralpunch compression bed 81 as well as the central punch vertical slidingmotion control roller 82, which are a one body with the central punch,protrude. As far as this punch is concerned, all details except for thereverse control of the movements of the central punch and the outerpunch are the same as the details in the punch shown in FIG. 6., soexplanations are omitted. Furthermore, since in the outer punch anopening section is set, troubles with friction due to adherence andmixing of powder granule are feared to occur so this punch is notconsidered to be of preferable construction. (Explanation of some ofreference numerals is omitted)

Next follows a detailed explanation of each section and its steps of theapparatus, corresponding to the first example of the present inventionmethod for the manufacture of moldings with core (FIG. 1), presented asthe present invention apparatus for the manufacture of moldings withcore or, in other words, as a rotary compression molding machine.Explanation is based mainly in FIGS. 9 and 10 and, if necessary, inFIG. 1. Powder granule is used as molding material in this form of theapparatus.

On top of a rotary table 1, following the direction of revolving, asshown in FIG. 9, powder granule supplying sections 8, 9, 10, powdergranule filling sections 11, 12, 13, powder granule leveling sections14, 15, 16, compression molding sections 17, 18, 19, 20, powder granuleresidue removal sections 21, 22 and a molding taking-out section 23, areset.

If each mechanism has to be explained separately, depending on the kindof powder granule to be supplied, the powder granule supplying sections(8, 9, 10 in FIG. 9) are divided into the section 8 for supplying ofpowder granule for the first outer layer OP1, the section 9 forsupplying of powder granule for the core NP and the section 10 forsupplying of powder granule for the second outer layer OP2; supplying ofpowder granule is performed by natural falling from a hopper 24, 25, 26that has filled each type of powder granule or by a fixed amountsupplying mechanism (not shown).

Each type of powder granule, supplied by the section for supplying ofpowder granule, are next sent to the section for filling powder granule(11, 12, 13 in FIG. 9). The section for filling of powder granule is asection for supplying of powder granule, used respectively for the firstouter layer OP1, the core NP and the second outer layer OP2, into thespace for the first outer layer 201A, the space for core 202A and thespace for second outer layer 203A (see FIG. 1). There, the differenttypes of powder granule, supplied by the section for supplying of corebodies, are maintained in fixed amount in an open feeding-plate 27, 28,29, which performs both the functions to store the powder granule and tosupply the powder granule. Then, by lowering the lower central punch 5A,using lowering devices 30, 31, 32 that are set on the frame 34 or bylowering the lower outer punch 5B, using a lowering device 33 that isset on the lower outer punch rail 36, the powder granule stored in theopen feeding-plate 27, 28, 29 is brought into the space for the firstouter layer 201A, the space for the core 202A and the space for thesecond outer layer 203A (see FIG. 1).

In details, the step of filling powder granule for the first outer layeris performed in the first open feeding-plate 27 on the rotary table 1 bylowering the lower central punch 5A (FIGS. 1A and 1B). Here the lowerouter punch 5B, using the lower punch vertical sliding motion controlroller 73, puts into motion the lower outer punch rail 36, which is setso that to put on same level the lower outer punch tip and the rotarytable 1; thus the lower outer punch maintains the same height as therotary table. On the other hand, the lower central punch 5A connects thelower central punch rail 35, set on the frame 34, with the rotary tablestep and is put into motion by the lower central punch bottom part 37(part which is essentially identical with the central punch compressionbed 79, shown in FIG. 6); furthermore, using the first central punchlowering device 30, set on the lower central punch rail 35, it regulatesthe mechanism in fixed position. Thus powder granule for the first outerlayer OP1 is brought into the space for the first outer layer 201A,which is above the lower central punch 5A and enclosed by the lowerouter punch 5B.

Next, the step of filling the powder granule for core NP is performed inthe second open feeding shoe 28 on the rotary table 1, in a way similarto that of the first outer layer OP1 by lowering the lower central punch5A only (FIGS. 1E and 1F). Here, using the lower outer punch verticalsliding motion control roller 73, the lower outer punch 5B puts intomotion the lower outer punch rail 36, which is set in order to level thelower outer punch 5B tip with the rotary table 1, and thus maintains itsheight with the rotary table at a fixed level. On the other hand, thelower central punch 5A, which maintained the first outer layer temporarymoldings on its upper edge 7A, puts into motion the lower central punchrail 35, set on the frame 34, using the lower central punch bottom 37that moves connected with the step of the rotary table. Furthermore thelower central punch 5A lowers the lower central punch rail 35, using thesecond central punch lowering device 31, set on the lower central punchrail 35. Thus the powder granule for core NP is brought into the spacefor the core 202A, enclosed by the lower outer punch 5B and above thefirst outer layer temporary moldings.

Next, the step of filling the powder granule for the second outer layerOP2 is performed in the third open feed shoe 29 on the rotary table 1,by lowering both the lower central punch 5B, that still holds thetemporary molded first outer layer OP1 and the core NP, and the lowerouter punch 5B or only the lower outer punch 5B (FIGS. 1I and 1J). Herethe lower outer punch 5B is lowered using the lowering device for lowerouter punch 33, set on the lower outer punch rail 36. Further, the lowercentral punch 5A, using the lower central punch bottom 37, which movesconnected with the step of the rotary table, puts into motion the lowercentral punch rail 35 and then lowers it, using the third central punchlowering device 32, set on the lower central punch rail 35. Thus, bylowering both the lower central punch 5A and the lower outer punch 5B,or the lower outer punch 5B only, the powder granule for the secondouter layer OP2 is brought into the space for the second outer layer203A, in the die 3 above first the outer layer OP1 and the core NPtemporary moldings and around them.

In FIG. 10 the third open feed shoe 29 is printed in bigger format thanthe other open feed shoes, but this is in order to show the details moreexplicitly. Furthermore, instead of the open feed shoe, a stirring feedshoe, which fills the powder granule into the die by force usingstirring blades, can be used. (The stirring feed shoe is set at the sameplace as the open feed shoe; not shown).

Next, the die, filled with the powder granule in the powder granulefilling section, and the punches enter in the powder granule levelingsection (14, 15, 16 in FIG. 9). The powder granule leveling sectioncontrols in a fixed amount the powder granule for the first outer layerOP1, the powder granule for the core NP and the powder granule for thesecond outer layer OP2, supplied as described above. In other words,using the lower outer punch rail 36 and the lower central punch rail 35,this section raises the lower central punch 5A or both the lower centralpunch 5A and the lower outer punch 5B to a fixed position and thus,using the leveling boards 38, 39, 40, files through the left-over of thepowder granule that has overflowed from the appointed space and removesit.

Speaking in details, the leveling of the powder granule for the firstouter layer OP1 is performed with the leveling board 38, which isattached to the first open feed shoe 27 on the revolving board 1. Here,as the tip of the lower outer punch 5B is on the same plane with therotary table, by raising the lower central punch 5A to a fixed position,the left-over of the powder granule for the first outer layer OP1 thatare filled in the space for the first outer layer 201A is forced tooverflow out of this space. Next, the powder granule for the first outerlayer OP1, that have overflowed, are filed through by the leveling board38, attached to the open feed shoe 27 and the filled powder granule forthe first outer layer OP1 are leveled to a fixed amount. (Before andafter FIG. 1B)

Next, the leveling of the powder granule for the core NP, is performed,same as in case of the first outer layer, with the leveling board 39,which is attached to the second open feed shoe 28 on the rotary table 1.Here, as the tip of the lower outer punch 5B is on the same plane withthe rotary table, by raising the lower central punch 5A to a fixedposition, the left-over of the powder granule for the core NP, that arefilled in the space for core 202A, is forced to overflow out of thisspace. Next, the powder granule for the core NP, that has overflowed, isfiled through by the leveling board 39, attached to the second open shoe28 and thus the filled powder granule for the core NP is leveled to afixed amount (before and after FIG. 1F).

Then, the leveling of the powder granule for the second outer layer OP2is performed, same as in case of the first outer layer and the core, bythe leveling board 40, attached to the third open feed shoe 29 on rotarytable 1. Here by raising the lower central punch 5A or both the lowercentral punch 5A and the lower outer punch 5B to a fixed position, thefirst outer layer and the core NP temporary moldings, held by the lowercentral punch 5A and the lower outer punch 5B, are pushed up into thepowder granule for the second outer layer OP2, which are supplied in theopening of the die 3 and the left-over of the powder granule for thesecond outer layer OP2 are forced to overflow. Then the powder granulefor the second outer layer OP2, that has overflowed, is filed through bythe leveling board 40, attached to the third open feed shoe 29, and thefilled powder granule for the second outer layer OP2 is leveled to afixed amount (after FIG. 1K).

Next, the die, filled with the fixed amount of powder granule, leveledin the powder granule leveling section, and the punches enter thecompression molding sections (17, 18, 19, 20 in FIG. 9). The compressionmolding section performs temporary or main compression of the powdergranule for the first outer layer OP1, the powder granule for core NPand the powder granule for the second outer layer OP2 any of themseparately or in combination (including the temporary moldings), whichare supplied in the fixed parts and the fixed amounts, using thecompression roller (44 to 51, 67 to 70), held by the frame 34.

Speaking in details, the temporary compression of the powder granule forthe first outer layer OP1 or of the first outer layer OP1 temporarymoldings and the powder granule for the core NP is performed bypressuring action of the upper central punch 4A and the lower centralpunch 5A. Here, the upper central punch 4A is lowered by the uppercentral punch lowering cam 41, 42, set on the upper central punch rail52, preferably at the same time the upper outer punch 4B is lowered to afixed position by the upper outer punch lowering cam 53, 54, set on theupper outer punch rail 56 and the tip of the upper central punch A4 isinserted in the space, enclosed by the lower central punch 5A and thelower outer punch 5B, in the die 3. Thus, by binding vertically thepowder granule for the first outer layer OP1 or the temporary moldingsfor the first outer layer OP1 and the powder granule for the core NP,filled in the appointed space and pressing them using the uppertemporary compression rollers 44, 46 and the bottom temporarycompression rollers 45, 47, step of molding of temporary compressedmaterials is performed. (FIG. 1C, FIG. 1G) Furthermore, it is possible,although not preferable, to skip the first section for moldings bytemporary compression of the powder granule for the first outer layerOP1.

Next, a preliminary compression (temporary compression) of the temporarymoldings of the first outer layer OP1 and the core NP and the powdergranule for the second outer layer OP2 is performed, using thecompression action of the upper central punch 4A and the upper outerpunch 4B (upper punch), and the lower central punch 5A and the lowerouter punch 5B (lower punch). In order to insert the upper central punch4A and the upper outer punch 4B into the die 3, the upper central punch4A and the upper outer punch 4B are lowered to an appointed position bythe upper central punch lowering cam 43, set on the upper central punchrail 52 as well as by the upper outer punch lowering cam 55, set on theupper outer punch rail 56, then their tips are inserted in the die 3,the temporary moldings of the first outer layer OP1 and of the core NPand the powder granule for the second outer layer OP2 are boundvertically and the preliminary compression molding is performed, usingthe preliminary compression roller for upper central punch 48, thepreliminary compression roller for the upper outer punch 67, thepreliminary compression roller for the lower central punch 49 and thepreliminary compression roller for the lower outer punch 68.

The main compression that follows the preliminary compression (temporarycompression) is a compression molding step of the temporarily compressedmoldings, using the main molding roller for the upper central punch 50,the main compression roller for the upper outer punch 69, the maincompression roller for the lower central punch 51 and the maincompression roller for the lower outer punch 70. (FIG. 1M) Furthermore,it is possible, although not preferable, to skip the section forpreliminary compression of the temporary moldings of the first outerlayer OP1 and the core NP and the powder granule for the second outerlayer OP2, and to perform only this main compression operation.

Next, the section for removal of powder granule residue (21, 22 in FIG.9), is in or immediately after the section for temporary compression ofthe powder granule for the first outer layer OP1 or the core NP. Asshown in FIG. 1, during the step of temporary molding or immediatelyafter it, as the tip of the lower outer punch 5B is on the same plane asthe rotary table 1 and, preferably, the upper central punch 4A isinserted in the space inside the lower outer punch 5B, the powdergranule for the first outer layer OP1 57A and the powder granule for thecore NP 57B, that have remained on the surface of the upper edge of thelower outer layer 7B, are removed by shooting of air under pressure andsuction.

Speaking in details, the upper edge surface 7B of the lower outer punch5B, shown in FIG. 1 fits with the edge of the circumference 76 (notright angle) of the completed moldings, shown in FIG. 13 and in thispart the powder granule residue 57 (57A, 57B) is left. This powdergranule residue 57 cannot be leveled and removed by the open feed shoe,set on the rotary table 1 and by the leveling board 38, 39 of thestirring feed shoe and when the powder granule residue is not removed,contamination between the powder granule for the first outer layer OP1and the powder granule for the core NP, as well as contamination betweenthe powder granule for the core NP and the powder granule for the secondouter layer OP2, is feared. For this reason after temporary compressionoperation, the powder granule residue 57 (57A, 57B) is removed by thefirst powder granule residue removal unit 21 and the second powdergranule residue removal unit 22, set on the rotary table 1 (FIGS. 1D and1H). The mechanism for removal of powder granule residue, for example asshown in FIG. 12, is placed on the rotary table parallel to thedirection of revolving, so as to press on both sides the die and thepunches, and consists of a nozzle for shooting of air under pressure 60,shooting air under pressure from four sides into surface of the die anda suction box 58, 61 with a suction opening 59, sucking powder granuleresidue. The nozzle for shooting of air under pressure 60 shoots towardsthe punches and the die from four sides and by the suction opening 59,which is placed close to the die, sucks the powder granule residue, sothat the powder granule residue 57 is not scattered outside but istotally removed. This device for removal of powder granule residue isthe device for removal of powder granule residue of the presentinvention. Furthermore, in some cases this unit for removal of powdergranule residue could be omitted. Especially when moldings with flatsurface is manufactured, since the surface of the outer punch is alsoflat, the unit for removal of powder granule residue is not necessary.

Finally the obtained moldings are sent to the unit for taking out ofproducts (23 in FIG. 9) to be discharged out of the molding machine. Theunit for taking out of products is placed so as to take out the readyproducts, using the lower central punch 5A and the lower outer punch 5B,which rise and thus push up the products and the scraper 71, which leadsthem to the chute 72.

Speaking in details, by raising the upper central punch 4A and the upperouter punch 4B, using the upper central punch raising cam 62 and theupper outer punch raising cam 63 and putting them in a position so as tofollow slanted surface, the tips of these punches are taken out of thedie 3; then, using the lower central punch push up rail 66 and the lowerouter punch push up rail 65, the lower central punch 5A and the lowerouter punch 5B are pushed up and the molding 64 in the die 3 are pushedcompletely out of the die 3. Furthermore, in order to make the step oftaking out of moldings easier, it is preferable to keep the surface ofthe tip of the lower outer punch 5B so as to be on the same level withthe rotary table surface and lower central punch 5A to be pushed up alittle bit higher than it (FIG. 1N). In order to be discharged out ofthe rotary table 1, the pushed out molding 64 are taken by the scraper71 and are led into the chute 72. Thus the products are taken out.

In FIG. 10, in the apparatus of the present invention, the followingdevices are shown as means to put into motion the central punch and theouter punch: a rail (a lower outer punch rail 36, a lower central punchrail 35, an upper outer punch rail 56, an upper central punch rail 52),a declining mechanism (a first central punch declining mechanism 30, asecond central punch declining mechanism 31, a third central punchdeclining mechanism 32, a declining mechanism for lower punch 33), araising cam (an upper central punch raising cam 62, an upper outer punchraising cam 63), a lowering cam (an upper central punch lowering cam 41,42, 43, an upper outer punch lowering cam 53, 54, 55), a push up rail (alower central punch push up rail 66, a lower outer layer push up rail65), as well as a vertical sliding motion control roller (a lower outerpunch vertical motion control roller 73, a upper outer punch verticalsliding motion control roller 74), a central punch bottom unit 37 and abearing 77. Furthermore, as means that enable the compression operationsof the central punch and the outer punch, the following devices areshown: a compression roller (an upper temporary compression roller 44,46, a bottom temporary compression roller 45, 47, a preliminarycompression roller for upper central punch 48, a preliminary compressionroller for upper outer punch 67, a preliminary compression roller forlower central punch 49, a preliminary compression roller for lower outerpunch 68, a main compression roller for upper central punch 50, a maincompression roller for upper outer punch 69, a main compression rollerfor lower central punch 51, a main compression roller for lower outerpunch 70) as well as an outer punch compression bed 78 and a centralpunch compression bed 79, shown in FIG. 6. Still more, these includefactors not only of the apparatus itself, but also factors of thepunches.

Among the means that put into motion the central and the outer punchesand enable the compression operations of the central and the outerpunches, as already was explained in the part concerning the punches,besides the methods, shown in FIG. 10, to control the movement of theouter punch by the vertical sliding motion control roller and the rail,and the movement of the central punch by the central punch bottom unitand the rail (corresponding to the punch in FIG. 6), methods, shown inFIG. 11, to control the movement of the central punch by a verticalsliding motion control roller and a rail, and the movements of the outerlayer by a punch bottom unit and a rail are also possible. As previouslydescribed and shown in FIG. 7, for execution of the latter methods it isnecessary to set an opening section in the outer punch so they couldcause troubles such as friction due to mixing of the powder granule, andtherefore the former methods are considered as preferable.

Furthermore, FIG. 11, just like FIG. 10, corresponds to the firstexample (FIG. 1) of the present invention method for manufacturingmoldings with core. The movement of the punches here is controlled in areverse way to that of FIG. 10 and therefore there are some parts withdifferent names, but the basic mechanisms are the same as in FIG. 10, sothe explanation of names and symbols is omitted. The symbols in FIG. 11concerning the parts with different names from the ones in FIG. 10, dueto reverse control, have a C attached to the symbol of the correspondingparts in FIG. 10.

In case of manufacturing of moldings having plural cores, using theapparatus for the manufacture of moldings with core of the presentinvention, depending on the number of cores and of outer layers thatseparate one core from the other, on the same rotary table are fedsections which perform moldings from step of supplying of cores or outerlayers, as well as a unit for removal of powder granule residue. Inother words, on the rotary table in FIG. 9, together with the unit forremoval of powder granule residue, necessary number of sections,performing molding from step of supplying cores, are fed.

The apparatus, used in the second example (FIG. 3) of the presentinvention's method for the manufacture of moldings with core, isbasically the same as the apparatus, used in the first example that wasexplained in details. The differences are in the means for putting intomotion the punches and in the means for compression, as well as in thefact that in the second example the unit for removal of powder granuleresidue is only one. Furthermore, the apparatus used in the thirdexample of the present invention's method for the manufacture ofmoldings with core, is the same as the apparatus, used in the first andthe second example.

Up to here explanations have been provided, concerning the presentinvention's method for the manufacture of moldings with core and theapparatus for its application, but from here on explanations will beprovided concerning the concrete molding, manufactured by the presentinvention's method and the apparatus for the manufacture of moldingswith core.

The moldability in the present invention could be defined by hardnessand friability, etc. Here, in case that hardness is below 3 kg orfriability is above 1% per 100 revolutions, the moldability are definedas low and a molding with low moldability is defined as a defectivemolding.

Furthermore, “friability” as term in the field of techniques formanufacturing of medical supplies, denotes the ability of the moldedtablet to endure vibration and shock during transportation as well asthe ability to endure the next process of coating, which ability ismeasured by the decreased amount of tablet weight, using a friabilitytesting mechanism with a revolving drum. More specifically, followingreference information “Method for testing friability of tablet” ofJapanese Pharmacopoeia 13, second revised appendix (same as USP 24General/information <1216> TABLET FRIABILITY), a drum with an electricalmechanism is set to revolve with 24 to 26 revolutions per minute, theweight of the tablet before and after a fixed cumulative number ofrevolutions is measured and calculated percentage of the decreasedweight of tablet as compared with the weight of tablet in the beginningis called degree of friability. In the present invention friability ismeasured by changing the cumulative number of revolutions.

Next, degree of hardness is one index to appraise hardness of thetablet. Testing methods to measure degree of hardness of tablet includean unbreakability testing method, where kinetic elasticity rate ismeasured by super sonic waves, and breakability testing methods such astesting breakability under compression, strain testing, shock testing,etc. In medicine and food products fields, the method for testingbreakability under pressure is employed most often. “Hardness” in thepresent description denotes hardness tested by the method for testingbreakability under pressure. The method for testing breakability underpressure is to measure the load to break a tablet by pressurizing onboth sides of the tablet in diameter direction. In other words, it is amethod to show moldability of the tablet from combined force at thebreaking section of the tablet.

Next, in the present description, the term “main ingredient” includesactive molding material (effective molding material, main ingredient) inmedical products field and main ingredient in food products field; allother molding material except main ingredient that is usually used asadditives in medicine manufacturing techniques are united under the term“excipient, etc.” and include excipient, binder, disintegrator,lubricant, agglutination preventing agent, etc.

A characteristic of the molding with core of the present invention isthat they consist of a core part and an outer layer part, molded in onebody. Here molding in one body means compression molding performed by aseries of steps, using one set of punches and die only. The traditionala molding with core were manufactured by molding of a core in advanceand in a different molding machine and then supplying it halfway throughthe molding step of moldings with core. For this reason moldings in onebody carries contrasting implication.

In the molding with core of the present invention, molding material withpoor moldability and molding material with good moldability can bedistributed unevenly, which is to say it is possible to have a moldingwith core that maintain moldability only in the outer layer, while inthe core the molding is incomplete. Here an incomplete molding, asdefined above, a molding with degree of hardness below 3 kg or a moldingwith degree of friability over 1% per 100 revolutions. In the moldingwith core of the present invention it is possible to lower themoldability of core part even further, so as to produce a molding withcore with degree of hardness of core below 2 kg or level of friabilityover 1% per 25 revolutions. It is possible to lower the moldability ofthe core part even further, so as to produce a molding with core withdegree of hardness of core below 1 kg or degree of friability over 5%per 25 revolutions. The moldability of the outer layer are the verything that determines the moldability of the whole molding, so as itsdegree of hardness is above 3 kg and degree of friability is below 1%per 100 revolutions, there are no problems with the moldability of thewhole molding.

For example, as in medical products and foods fields, usually the mainingredient is of poor moldability, in the present invention a moldingwith core it is possible to put the greater part of main ingredient withpoor moldability in the core and to feed excipient with good moldabilityas a greater part of the outer layer. In other words it is possible tomake a molding with core that contain over 80% main ingredient and below20% excipient in the core and below 20% main ingredient and over 80%excipient in the outer layer.

It is also possible to make a molding with core, where, after wholeamoung of main ingredient is molded into core, the amount of excipientin the core is made below 20% or below 10% and the outer layer is madeonly of excipient of good moldability. Furthermore, it is also possibleto make a molding with core, where the core is made only of mainingredient with poor moldability, or of main ingredient and lubricant(including excipient that can produce effect like that of lubricant), orof main ingredient and agglutination preventing agent (includingexcipient that can produce effect like that of agglutination preventingagent), or of main ingredient, lubricant and agglutination preventingagent in other words a molding with core where the core is made only ofmain ingredient and no excipient that improve moldability are included.Thus, breakability and solubility of active molding material can also beimproved.

Since the a molding with core in the present invention are manufacturedby molding in one body, there is no offset in positioning of the core asin the traditional molding with core, it is possible to make the outerlayer extremely thin and there is no unevenness between the differentmoldings. Therefore it is possible to make the thickness of the outerlayer in all parts below 1 mm or even below 0.9 mm, and also tomanufacture such moldings with core on a large scale. In other words,the usefulness of the moldings with core of the present inventionbecomes even clearer when they are taken as multiple aggregate, so theycould be represented as an aggregate of moldings with core, wherethickness of the outer layer in all parts is below 1 mm or even below0.9 mm. Thinning of the outer layer contributes to the miniaturizationof a molding. Here the outer layer is the part, decided by the openingbetween the central punch and the die (the thickness of the outer punchtip part) and is defined as an outer layer part on the side of amolding, formed on the plane vertical to diameter plane of the molding(plane, perpendicular to the direction of pressurization) (FIG. 13, 80).Even in the prior art the thickness of the vertical section of a moldingouter layer could be controlled by the amount of powder granulesupplied, so by the superiority of the present invention is displayedreducing the thickness of the molding to the thickness of outer layer.

In the present description an aggregate denotes multiple moldings,manufactured on a large scale. Speaking in details, it is possible thatthe aggregate includes, for example, more that 100 moldings, or, in somecases more than 1000 or more than 10000.

Next follows a detailed explanation of the application of the presentinvention's molding with core in medical products and foods field.

The shape of the present invention's molding with core is notrestricted, as far as it is easy to hold and to swallow, but in medicalproducts field medicines with circular or oval shape are preferable.

The size of the present invention's molding with core is not unified,since there is difference between the individual moldings, as far asthey are easy to swallow and, for example, in case of circular tablet itshould be below 13 mm in diameter, in general between 4 mm to 13 mm indiameter and preferably between 5 mm to 11 mm in diameter. However, whena molding that is to be chewed is manufactured, the shape and the sizeshould be measured so as to enable insertion into the oral cavity andeasy chewing for example in case of circular tablet, the size should bebelow 25 mm in diameter, generally between 4 mm to 25 mm in diameter andpreferably between 6 mm to 16 mm in diameter.

As far as the size of the core part is concerned, in order to preventincrease in the size of the whole molding, it is preferable to make thecore as small as possible, but in order to perform the step of moldingof core smoothly, it is not preferable to make it too small. Finally, incase of circular tablet, the core should be between 2 mm to 11 mm indiameter, preferably between 3 mm to 9 mm in diameter. However, when amolding that is to be chewed is manufactured, the size of the core incase of circular tablet for example should be below 23 mm in diameter,generally between 2 mm to 23 mm in diameter, preferably between 4 mm to14 mm in diameter.

The shape of the core depends on the shape of the central punch, but ingeneral it is in keeping with the above shape of the molding with core.

The thickness of the compression covering layer, in correspondence withthe size of the core should be with low friability and ability tomaintain the shape of molding and usually it is between 1 mm to 2.5 mm,but in this method for molding in one body, it could be below 1 mm, oreven below 0.9 mm. However, when a molding that is to be chewed ismanufactured, since it is better not to raise the degree of hardnessmore than necessary, it is preferable to make the compression coveringlayer as thin as possible, but enough thick so that to have lowfriability and to be able to maintain the shape of the molding.

Molding material that can maintain the shape of molding with core andthat can be taken orally should be selected as molding material for thecompression covering layer. There are no special restrictions, but isbetter to use one or combination of two molding materials with goodcompression moldability. The following excipients and binders can bedescribed as molding material with good compression moldability:crystalline cellulose, lactose, sorbitol, maltitol, powderedhydorgenated maltose starch syrup, calcium hydrogen phosphate, anhydrouscalcium hydrogen phosphate, silicate aluminate magnesium, meta silicatealuminate magnesium (all the above are excipient, following are binder),hydroxipropylcellulose, hydroxipropylmethylcellulose, alpha starch,carboxyvinyl polymers, polyvinyl alcohols, polyvinyl pyrrolidone,methylcellulose, gum arabic, pullulan, etc. Among them, preferable arecrystalline cellulose and sorbitol.

In the compression covering layer and the core of molding with core inthe present invention, different types of additives, generally used inmedicine manufacturing techniques, can be used, such as excipient,binding agent, disintegrator, lubricant, agglutination preventing agent,etc. (combined under the common term “excipient, etc.”). These additivescan be used in amount, which is within the limits of their usual use inthe field of medicine manufacturing techniques. However molding materialthat cannot be used in medicines and foods differ.

The excipients and binding agents are recorded as molding material withgood compression moldability. As disintegrators carboxymethylcellulosecalcium, cross-carmellose calcium, low substitution degreehydroxypropylcellulose, polyvinyl pyrrolidone, etc. can be described; aslubricants and agglutination preventing binders magnesium stearate,sucrose fatty acid ester, hydrate dioxide silicon etc., can bedescribed.

The medical active molding material that appropriate the main part ofthe molding with core in the present invention are not subjected tospecial limitations, as long as they could be administered orally, butthe following could be recorded as medicines with strong effect:medicines that affect the central nervous system, medicines that affectthe circulatory organs, medicines that affect the respiratory organs,medicines that affect the digestive organs, antibiotics as well aschemical treatment medications, medicines that affect the metabolism,vitamins, antacids, etc. One type, two types and more of these medicinescan be used. Most of their active molding material are of poormoldability so they cannot be molded separately.

The functional food molding material that appropriate the main part ofthe molding with core in the present invention are not subjected tospecial limitations, as long as they could be administered orally. Thefollowing molding material can be described as functional food moldingmaterial: molding material that affect the control of physical conditionrhythm, molding material that affect the bio-defense, molding materialthat affect the disease prevention, molding material that affect therecovery from diseases and molding material that affect the suppressionof ageing. One type, two types and more of these active food moldingmaterial can be used.

The general food molding material that appropriate the main part of themolding with core in the present invention are not subjected to speciallimitations, as long as they could be administered orally. Sweets andseasonings can be described as related foods.

These medical active molding material, functional food molding materialand general food molding material (all defined with the common term“main ingredient”), are contained mainly in the core of the molding withcore of the present invention, and if necessary, part of them could beput also in the compression covering layer, which is the outer layer.The combination amount of these main ingredient in the core should bedetermined according to the effective dosage of active molding materialin the used medications or functional foods. The same goes for thegeneral food molding material and there are no special limitations, butthe combination amount should be between 30 to 100% of the mass of thecore and the preferable amount is 60 to 100% of the mass of the core.

Furthermore, the molding material in the core and the compressioncovering layer could be used as they are, but, by following the generalmethod, once the molding material could also be granulated and powdergranule could be adjusted and then used. The powder granule togetherwith the binding agents could also coat on an inactive carrier themedical active molding material, functional food molding material andgeneral food molding material.

Next follows a simple explanation of the application of the products ofthe present invention in the fields of electronic parts, agriculturalchemistry, sanitary products, etc.

In these cases, unlike in case of the medical products and foods, wherethe size and shape of the molding with core and the size and shape ofthe core should be made so as to enable insertion of the products in theoral cavity, the size and shape of molding with core and the size andshape of core are not subjected to any special limitations and as far asthe shape of the punches allows, they should be made so as to suit thefunctions and the purpose of the molding with core. The same goes forthe thickness of the compression covering layer, which should be made soas to maintain the moldability. The molding material of the core is alsonot subjected to any special limitations and anything that suits thefunctions and the purpose of the molding with core is allowed.

Next follows a detailed explanation of the molding with core in thepresent invention, accompanied by practical examples.

Experimental Example 1 Manufacture Example 1

On the surface of the punches of a double structure with inside diameterof 8.5 mm and outside diameter of 10.0 mm and with pressurizable flatedge, a small amount of magnesium stearate (manufactured by TaiheiKagaku Sangyo) was applied and as the lower central punch was kept inlowered position, in the space above the lower central punch, enclosedby the lower outer punch, 15 mg crystalline cellulose (manufactured byAsahi Kasei: Avicel PH-101) was supplied; then the upper central punchand the lower central punch were moved towards each other andcompression was applied manually so as the surface to become flat. Next,as the lower central punch was kept in lowered position, in the spaceabove the temporary moldings of crystalline cellulose, enclosed by thelower outer layer, 300 mg of ascorbic acid (manufactured by Merck Japan:L-ascorbic acid crystal) were supplied; then the upper central punch andthe lower central punch were moved towards each other and temporarycompression was applied manually so as to be able to maintain themolding shape. Next, as the bottom layer was kept in lowered position,in the space in the die above and around the molding, made ofcrystalline cellulose and ascorbic acid, the remaining 60 mg ofcrystalline cellulose (manufactured by Asahi Kasei: abicell PH-101) weresupplied and the temporary ascorbic acid moldings were completelyenclosed in crystalline cellulose; then the upper central punch and thelower central punch were moved towards each other and, using a hydraulichand press (manufactured by Shimazu Seisakusho: SSP-10A), the tablet wasmade with compression force of about 1.4 ton. Weight of the tablets was375 mg per tablet, thickness of the tablet was 3.40 mm and thickness ofthe outer layer was 0.75 mm.

Comparative Manufacture Example 1

375 mg of ascorbic acid (the same as above) were weighed and filled inthe die and then, using a punch with 10.0 mm in diameter flat edge withmagnesium stearate (the same as above), applied on the surface of boththe upper and the lower punches and a rotary tableting machine(manufactured by Hata Tekkojo: HT-AP18SSII), by applying pressure ofabout 1.4 ton on the punches, tablet was made manually. Weight of thetablets was 372 mg per tablet, and thickness of the tablet was 3.40 mm.

Comparative Manufacture Example 2

150 g of ascorbic acid (the same as above) and 37.5 g of crystallinecellulose were mixed in 100 revolutions by a micro V shaped mixer(manufactured by Tsutsui Rikagaku Kiki) 375 mg of the mixture wereweighed and filled in the die and then, using a punch with 10.0 mm flatedge with magnesium stearate (the same as above), applied on the surfaceof both the upper and the lower punches and a rotary tableting machine(the same as above), by applying pressure of about 1.4 ton on thepunches, tablet was made manually. Weight of the tablets was 374 mg pertablet and thickness of the tablet was 3.41 mm.

[Evaluation of Friability 1]

Evaluation of friability of the tablets of the manufacture example andthe comparative manufacture examples was performed in accordance withreference information “Method for testing friability of tablet” ofJapanese Pharmacopoeia 13, second revised appendix (same as USP 24General/information <1216> TABLET FRIABILITY) and using a drum withelectrical mechanism (ELECTROLAB: EF1-W). Hardness of tablets wasmeasured using a device for measuring breakability strength(manufactured by Toyama Kagaku). The results are shown in Table 1.

TABLE 1 Number of cumulative Hardness revolutions of drum of tabletsSamples 25 100 250 375 500 (kg) Manufacture 0.00 0.03 0.05 0.05 0.08 3.8example 1 Comparative 9.28 — — — — 0.7 manufacture example 1 Comparative0.05 0.91 4.09 5.89 7.91 3.9 manufacture example 2 * Numbers in thecolumns show degree of friability. The unit is percents. * “—” standsfor impossibility to measure.From the table 1 it becomes obvious that when the cumulative number ofrevolutions of the drum exceeds 25, the tablets with ascorbic acid ofcomparative manufacture example 1 break and the degree of friabilitycannot be measured, which shows that ascorbic acid is ingredient withextremely poor moldability. It could be surmised that the core part ofmanufacture example 1 also is with very poor moldability. The sametendency was noticed in respect to the degree of hardness of thetablets.

Although manufacture example 1 and comparative manufacture example 2contained the same amount of ascorbic acid with extremely poormoldability and the excipient molding materials were also the sameamount and same type, the results for friability were very different.While in manufacture example 1 friability was unnoticed even after thedrum made 500 revolutions, in comparative manufacture example 2 about 8%of the tablet's weight was worn out. From the above results it becameclear that when molding materials with low friability and poormoldability are molded, if the molding are the same as in manufactureexample 1, friability could be improved immensely.

Experimental Example 2

The results of experimental example 1 showed that the tablets ofmanufacture example 1 possess superb degree of friability. Thecombination proportion of ascorbic acid and crystalline cellulose, whichwould allow the same degree of friability as in manufacture example 1while weight of the tablet is unchanged, in the traditional methods formanufacturing of ordinary tablets (same as comparative manufactureexample 2) was evaluated.

Comparative Manufacture Example 3

131.5 g of ascorbic acid (manufactured by Merck Japan: L-ascorbic acidcrystals) and 56 g of crystalline cellulose (manufactured by AsahiKasei: abisel PH-1) were mixed at 100 revolutions in a micro V-shapedmixer (manufactured by Tsutsui Rikagaku Kiki) 375 mg of the mixture wereweighed and filled in the die and then, using a punch with 10.0 mm indiameter flat edge with magnesium stearate (manufactured by TaiheiKagaku Sangyo), applied on the surface of both the upper and the lowerpunches and a rotary tableting machine (manufactured by Hata Tekkojo:HT-AP18SSII), by applying pressure of about 1.4 ton on the punches, atablet was made manually. Weight of the tablets was 374 mg per tablet.

Comparative Manufacture Example 4

112.5 g of ascorbic acid (the same as above) and 75 mg of crystallinecellulose (the same as before) were mixed in a micro V-shaped mixer (thesame as before) at 100 revolutions. 375 g of the mixture were weighedand filled in a die and then, using a punch with 10.0 mm flat edge withmagnesium stearate (the same as above), applied on the surface of bothupper and lower punches and a rotary tableting machine (the same asbefore), by applying pressure of about 1.4 ton on the punches, a tabletwas made manually. Weight of the tablet was 375 mg.

Comparative Manufacture Example 5

93.7 g of ascorbic acid (the same as before) and 93.8 g of crystallinecellulose (the same as before) were mixed in a micro V-shaped mixer (thesame as before) at 100 revolutions. 375 g of the mixture were weighedand filled in a die and then, using a punch with 10.0 mm flat edge withmagnesium stearate (the same as above), applied on the surface of bothupper and lower punches and a rotary tableting machine (the same asbefore), by applying pressure of about 1.4 ton on the punches, a tabletwas made manually. Weight of the tablet was 375 mg.

[Evaluation of Friability 2]

The evaluation of friability was performed according to the previousevaluation of friability 1. The results are shown in table 2.

TABLE 2 Number of cumulative Hardness revolutions of drum of tabletsSamples 25 100 250 375 500 (kg) Comparative 0.05 0.91 4.09 5.89 7.91 3.9manufacture example 2 80:20 Comparative 0.08 0.24 0.62 1.56 2.74 6.9manufacture example 3 70:30 Comparative 0.00 0.05 0.16 0.21 0.32 11.5manufacture example 4 60:40 Comparative 0.00 0.05 0.03 0.05 0.05 16.5manufacture example 5 50:50 Manufacture 0.00 0.03 0.05 0.05 0.08 3.8example 1 80:20 * Numbers in the columns show degree of friability. Theunit is percents. * The ration below the type of testing showsproportion of the combination ascorbic acid:crystalline cellulose.

Table 2 shows that in order to achieve same friability as in manufactureexample 1 at the same weight of tablets, using traditional methods formanufacturing (comparative manufacture examples 2 to 5) the proportionratio of ascorbic acid that is of poor moldability and of crystallinecellulose that improves moldability should be 50:50. In other words, ascompared with tablets, manufactured according to the traditionalmethods, where the amount of ascorbic acid must be decreased in order tosolve the problems with friability, in the tablets, manufactured by thepresent invention, that have same degree of friability at the sameweight (manufacture example 1), the amount of ascorbic acid could be 1.6times the amount of ascorbic acid in the tablets, manufactured accordingto the traditional methods. From these results it becomes clear thatwhen the amount of ascorbic acid in the compression-coated tablets ofthe present invention is kept the same, the tablets could be madesmaller and lighter.

From the comparison between the weight of tablets of manufacture example1 and of tablets of comparative manufacture example 5, that have almostthe same degree of friability, it becomes clear that the tablets of thepresent invention (manufacture example 1) have superb degree offriability, but despite this their hardness does not increase more thannecessary, so they are very suitable for chewing.

Experimental Example 3

The results of manufacture example show that the tablets of comparativemanufacture example 1 have poor moldability and high degree offriability. For this reason evaluation of the pros and cons ofmanufacturing of compression-coated tablets with poor moldability by thetraditional manufacturing methods was performed (comparative manufactureexample 6). The core supplying mechanism of the compression-coatedtablets making mechanism (manufactured by Hata Tekkojo: HT-AP33-C)cannot be applied for formatting the tablets in the comparativemanufacture example 1 (there are problems with supplying the core pillsin the die), so the shape of the tablets was changed to 6.5 mm indiameter ordinary R and ascorbic acid was used, which is same ascomparative manufacture example 6.

Comparative Manufacture Example 6

748 g of ascorbic acid (manufactured by Merck Japan: L-ascorbic acidcrystals) and 2 g magnesium stearate (manufactured by Taihei KagakuSangyo) were mixed at 100 revolutions in small V-shaped mixer(manufactured by Tsutsui Rikagaku Kiki) The mixture is compressed in arotary tableting machine (manufactured by Hata Tekkojo: HT-AP18SSII),using punch of 6.5 mm in diameter ordinary R and by applying pressure ofabout 0.7 ton on the punch and then is made into tablets. The weight ofthe tablets made was 101 mg per tablet and the degree of hardness was0.3 kg. Some of the tablets broke during the handling and it wasimpossible to measure the degree of friability. Breaking and wearing outof tablets in the supply route, in the die or on the table were fearedand therefore the decision was that compression-coated tablets,manufactured following the traditional methods, are impossible.

[Results]

When compression-coated tablets are of poor moldability, there areproblems such as breaking and wearing out of the tablets in the supplyroute, so manufacturing of compression-coated tablets by the traditionalmethods was impossible.

Experimental Example 4

Experimental example 3 showed that when only ascorbic acid is used asingredient for core, due to insufficient moldability of the core it isimpossible to make tablets using the traditional device for makingtablets (manufactured by Hata Tekkojo: HT-AP33-C). The same test wasperformed, using taurine as ingredient for compression-coated tablets.

Manufacture Example 2

On the surface of punches of a double structure with inside diameter of8.5 mm and outside diameter of 10.0 mm and with flat edge, small amountof magnesium stearate (manufactured by Taihei Kagaku Sangyo) was appliedand as the lower central punch was kept in lowered position, in thespace above the lower central punch, enclosed by the lower outer punch,30 mg crystalline cellulose (manufactured by Asahi Kasei: abicellPH-101) was supplied; then the upper central punch and lower centralpunch were moved towards each other and temporary compression wasapplied manually so as the surface to become flat. Then, as the lowercentral punch was kept in lowered position, in the space above thetemporary moldings of crystalline cellulose, enclosed by the lower outerlayer, 300 mg taurine (manufactured by Iwaki Seiyakujo: taurine “Iwaki”aminoethyl sulfonic acid) were supplied; then the upper central punchand the lower central punch were moved towards each other and temporarycompression was applied manually so as to maintain moldings. Next, asthe lower punch was in lowered position, in the space above and aroundthe temporary moldings of crystalline cellulose and taurine, theremaining 70 mg crystalline cellulose (the same as above) were fed sothat the temporary moldings of taurine was completely enclosed incrystalline cellulose; then the upper punch and the lower punch weremoved towards each other and tablets were made by compression of about1.4 ton, using hydraulic type hand press device (manufactured by ShimazuSeisakusho: SSP-10A). The weight of tablets was 393 mg per tablet, thethickness of the tablets was 3.92 mm and the thickness of the outerlayer was 0.75 mm.

Comparative Manufacture Example 7

300 mg of taurine (the same as above) were weighed and filled in the dieand then, using a punch with 8.5 mm flat edge with small amount ofmagnesium stearate (the same as above), applied on the surface of bothupper and lower punches and a rotary tableting machine (manufactured byHata Tekkojo: HT-AP18SSII), tablets were made manually with compressionof about 1.5 ton per punch. The weight of the tablets was 299 mg pertablet and their thickness was 3.78 mm.

[Evaluation of Friability 3]

Table 3 shows that the taurine containing tablets of comparativemanufacture example 7 are completely destroyed before the cumulativenumber of revolutions of the drum reaches 25 and the degree offriability cannot be measured, which means that taurine is an ingredientwith extremely poor moldability. The same tendency was confirmed for thehardness of the tablets. From this results it became clear that in thetraditional way of making compression-coated tablets the moldability ofcore were not good and therefore it is impossible to supply core, madeonly of taurine.

In contrast to that, the compression-coated tablets of the presentinvention of the manufacture example 2 have superb degrees offriability, despite the fact that the core is made only of taurine withvery poor moldability and in the same amount as in the comparativemanufacture example 7.

TABLE 3 Number of cumulative Hardness revolutions of drum of tabletsSamples 25 100 250 375 500 (kg) Manufacture 0.00 0.25 0.51 0.76 0.76 4.1example 2 Comparative — — — — — 0.7 manufacture example 7 *The values inthe columns show degree of friability in percents. *“—” showsimpossibility to measure.

Next follow explanations of the molding with core having plural cores,as part of the molding with core of the present invention.

The molding with core having plural cores of the present invention ismolding with plural cores having an outer layer and plural cores insidethe layer which are integrally molded. One of the features is that theplural of cores is placed vertically towards the compression plane ofthe molding. Here compression plane is the plane assumed to be verticalto the direction of pressurization by punches, which accepts thecompression. The direction, vertical to the compression plane of themolding is the same as the direction of compression of molding.

Plural cores means more than two cores, usually two to several cores,and the cores could be multiplied by simple repetition of the steps ofmolding of the core (outer layer and cores repeated molding step). Coresexist in the molding not only in connected form, but it is also possibleto separate them by outer layer, or even to make plural cores of thesame molding material as well as plural cores of different moldingmaterial. Thus in the field of medicines, for example, it is possible toseparate two or more types of molding material that are feared to haveside effects into different core.

Another characteristic of the molding having plural cores is that thepositioning of the cores is unified and they are distributed in specificpositions. The traditional methods also allowed manufacturing of moldinghaving plural cores, but the positioning of the cores was different foreach molding so it was impossible to manufacture on a large scalemolding having plural cores, where the cores were distributed tospecific unified positions. Therefore the usefulness of the moldinghaving plural cores becomes even clearer when they are made intoaggregates and the expression aggregates of moldings having pluralcores, characterized by unified and specific positioning of the corescould be used.

Thus, in the molding having plural cores in the present invention, theplural cores is distributed in decided positions, the outer layer couldbe made as thin as possible and therefore further miniaturization of themolding is possible.

The previous explanations of the molding with core of the presentinvention can be applied without changes for the molding having pluralcores of the present invention.

Next follow more detailed explanations of molding with core that containmicrocapsules and coated particles, as part of the molding with core ofthe present invention. In the present description microcapsules andcapsulated particles, which have lost their specifics, characteristicsand functions due to their poor moldability, high brittleness or damage,are called with the generic name particle clusters and are defined asmicrocapsule type granule. In other words, the microcapsule type granuleinclude every kind of coated granule such as microcapsules, seamlesscapsules, and mini-soft capsules, micro-spheres, as well asmacromolecular coated granule, wax coated granule, sugar coated granule,etc. There is also microcapsule type granule, which includes granulethat is feared to lose their activity in high-compression process ofmaking tablets and that can be formed as one-functional units, such asacetic ingredients containing granule, etc. The coated granule of everykind is granule with coating on the granule particle, granule in thegranule particle of which there is a core, granule in the granuleparticle of which there is a core and which have coating on the granuleparticle, and granule whose purpose is to improve their controlledrelease properties, lipid solubility, easy solubility, heat resistance,light resistance as well as stability and bitter taste.

The microcapsule type of granule that are used in this field are usuallywith diameter below 3 mm, preferably below 2 mm, and even below 1 mm.However, if they are granule that can be formed as functional units, thediameter is not subject to any special restrictions.

The structure of the molding with core of the present invention ischaracterized by core part, which contains microcapsule type of granule,and outer layer, which covers the core and is a compression-coveringlayer. Here the microcapsule type granule is in state of a multiplicityof aggregates. Preferably the outer layer should not includemicrocapsule type granule, but mainly molding material with superbmoldability, which is to say that preferably the whole amount ofmicrocapsule type granule should be contained in the core. It ispossible that the outer layer contains small amount of microcapsule typegranule, but is not preferable from content uniformity point of view.

The present invention succeeds in manufacturing of the molding,containing microcapsule type granule, where microcapsule type ofgranule, which is of poor moldability, is distributed unevenly in thecore part and the outer layer is composed of molding material of superbmoldability, where microcapsule type of granule is contained in largeamounts in the molding, due to inserting molding material of superbmoldability between the microcapsule type granule in the core and thusit succeeds in improving substantially the moldability and thefriability of the molding. The present invention also achieves easilythe degree of friability of molding, prescribed by reference information“Method for testing friability of tablet” of Japanese Pharmacopoeia 13,second revised appendix (same as USP 24 General/information <1216>TABLET FRIABILITY), which is below 1%. At the same time by decreasing asmuch as possible the fed amount of excipients it enabled theminiaturization of the molding. Furthermore, since the core in thepresent invention's molding with core, containing microcapsule typegranule, is distributed in a specific position, there are no offsets andthe outer layer could be made extremely thin, which also contributes tothe miniaturization of the molding.

Speaking in details, in the present invention's molding with core,containing microcapsule type granule, the moldability depend mainly onthe molding material of the outer layer and therefore molding materialwith superb moldability are fed mainly in the outer layer. Furthermore,by inserting molding material with superb moldability in themicrocapsule type granule in the core, or in other words, by feedingseparately molding material of superb moldability in the core, themoldability of the core are secured. In order to secure the moldabilityof the core, while preventing the increase in size of the molding, thepreferable fed amount of molding material with superb molding amounts inthe core should be between 10 and 120% by mass of the microcapsule typeof granule in the core. As a result, it is possible even with lowcompression to manufacture molding with superb moldability and degree offriability, and there is no necessity to perform granulation of themicrocapsule type granule in order to secure the moldability. Thus, itis possible to avoid problems such as damages of the capsule of themicrocapsule type granule or of the granule itself, due to outerpressure during steps of granulation and making of tablet.

The molding material with superb moldability, used in the presentinvention, are not subjected to any special limitations, but it ispreferable if they are molding material that can achieve sufficientmoldability at low pressure during making the tablets and these moldingmaterials can be used separately or in combinations. Such moldingmaterials of superb moldability are the same as described above.

Furthermore, in the molding with core, containing microcapsule typegranule, of the present invention, the traditional method of feedingmixed excipients and microcapsule type granule in the die are not used,but instead it is possible to apply the method of feeding separately inthe die the microcapsule type granule and the molding material of superbmoldability, such as excipients. Thus it is possible to avoid problemssuch as segregation of microcapsule type granule and excipients.Therefore, the molding with core, containing microcapsule type granule,of the present invention is molding with core with superb evendistribution of the microcapsule type granule in the molding and can besaid to be aggregates of moldings with core, containing microcapsuletype granule, characterized by unified amount of microcapsule typegranule in the core. Here unified amount denotes amount which is inconformity of Experimental method for unified amount of JapanesePharmacopoeia General Testing Methods 13^(th) Revision.

The size and shape of the molding with core, containing microcapsuletype granule, of the present invention are not subjected to any specialrestrictions, as far as they are in the allowed limits for manufacturingby the punch, and they can be made following the previous explanationsof molding with core and in accordance with their application. The samegoes for the size and shape of the core, but in order to secure itsmoldability it is not preferable to make the core too big against thesize of the whole molding, which is to say to make the outer layer toothin. To maintain the moldability, the thickness of the outer layershould be above 1 mm.

Next follow detailed explanations accompanied by execution examples,using microcapsules as microcapsule type granule. The measuring methodsof the physical properties of the tablet, the amount of microcapsulesand the difference in color of tablet are also shown below.

[Method for Measuring Degree of Friability (%)]

Manufacture example and comparative manufacture example evaluation oftablets friability was performed using drum with electrical mechanism(ELECTROLAB: EF1-W), following the “Method for testing friability oftablet” of Japanese Pharmacopoeia 13, second revised appendix (same asUSP 24 General/information <1216> TABLET FRIABILITY). The drumrevolutions were set to 24 to 26 revolutions per minute, then the weightof tablets was measured before and after a fixed cumulative number ofrevolutions and the percentage of diminished weight against the weightof the tablets in the beginning was calculated as degree of friability.

[Method for Measuring Content of Microcapsules (%)]

The content of microcapsules was calculated by measuring the weight ofthe microcapsules. First, the tablets or the mixture were preciselymeasured, then the tablets or the mixture were sieved using ethanol witha 48 Mesh sieve and the microcapsules only were separated. Then theseparated microcapsules were dried and precisely measured, the weight ofthe microcapsules was divided by the previously measured whole tabletsor mixture and the calculated percentage was the amount ofmicrocapsules.

[Color Difference of Tablets (ΔE)]

The color difference of front and back of tablets was measured usingcolor difference meter (manufactured by MINOLTA: CM3500d). The method tomeasure color difference was to calculate the difference betweensamples, defined by ΔL, Δa, Δb, which represent the difference ofcoordinates L*, a*, b* in the color surface system L*a*b*. The resultwas the color difference (ΔE*a b). Hereinafter (ΔE*a b) will beabbreviated to (ΔE).

[Evaluation of Destruction of Microcapsules during Tablet Molding Step]

The examination, judging whether the microcapsules were destructed ornot was performed by visual observation of whether the surface of thetablets is colored or not, after tablets, containing microcapsules withvitamin E and then immediately after the molding the vitamin E(tocopherol) is oozed out.

Experimental Example 5

Using degree of friability as index, the moldability of the tablet wasevaluated in reference to the following manufacture examples: thepresent invention's manufacture example 1M, with compression-coatedtablet where microcapsules are sandwiched by excipients in the form of alayer; comparative manufacture example 1M, where tablet is made bymixing physically microcapsules and excipients; comparative manufactureexample 2, where microcapsules are sandwiched by excipients in the formof a layer; comparative manufacture example 3, where tablet is made asmolding with core, without sandwiching the microcapsules by excipientsin the form of a layer.

Manufacture Example 1M

On the surface of the punches of a double structure with inside diameterof 6.0 mm and outside diameter of 8.0 mm and with flat edge, smallamount of magnesium stearate (manufactured by Taihei Kagaku Sangyo) wasapplied and, as the lower central punch was kept in lowered position, inthe space above the lower central punch, enclosed by the lower outerpunch 30 mg of granulated product of lactose and crystalline cellulose(manufactured by MEGGLE: Cellactose 80) were supplied; then the uppercentral punch and the lower central punch were moved towards each otherand compression was applied manually so as the surface to become flat.Then, as the lower central punch was kept in lowered position, in thespace above the temporary moldings of lactose and crystalline cellulose,enclosed by the lower outer punch, 30 mg microcapsules (manufactured byRikyuu Vitamins: beads of vitamin E and C) were fed; then the uppercentral punch and the lower central punch were moved towards each otherand temporary compression was applied manually so as the surface tobecome flat. Next, in the space above the temporary moldings made of thepreviously molded lactose and crystalline cellulose and microcapsules,enclosed by lower outer punch, 50 mg of granulated product of lactoseand crystalline cellulose were fed; then the upper central punch and thelower central punch were moved towards each other and temporarycompression was applied manually so as the surface to become flat. Next,in the space above the temporary moldings, made in the previous steps,the remaining 30 mg of microcapsules were supplied; then the uppercentral punch and the lower central punch were moved towards each otherand in the next step of temporary molding was performed to a degree,which could maintain moldability, enabling smooth transition. Finally,as the lower punch was kept in lowered position, in the space above andaround the temporary moldings, made in the previous steps, the remaining60 mg of granulated product of lactose and crystalline cellulose(manufactured by MEGGLE: Cellactose 80) were fed and as the temporarymoldings made of lactose and crystalline cellulose and microcapsuleswere completely enclosed in the granulated product of lactose andcrystalline cellulose, the lower punch and the upper punch were movedtowards each other and using hydraulic type hand press (manufactured byIuchi Seieido: 3 ton high pressure jack), tablets were made, applying ona tablet unit of square measure pressure of 7.9 kg/mm² (approximately400 kg per punch). The weight of the tablets was 197.1 mg per tablet andthe thickness of the tablets was 3.54 mm. There was no oozing out ofvitamin E on the surface of the pills, so it was confirmed that therewas no destruction of microcapsules.

Comparative Manufacture Example 1M

60 mg of microcapsules (the same as above) and 140 mg of granulatedproduct of lactose and crystalline cellulose (the same as above) wereweighed and after being mixed manually in a small bag with a fastener,the whole amount is filled in a die. Using a punch of 8.0 mm in diameterwith flat edge, on the surface of the upper and lower punches of whichsmall amount of magnesium stearate (the same as before) was applied anda hydraulic type hand press (the same as before), tablets were made,applying on a tablet unit of square measure pressure of 7.9 kg/mm²(approximately 400 kg per punch). The weight of the tablets was 194.6 mgper tablet and the thickness of the tablets was 3.52 mm. There was nooozing out of vitamin E on the surface of the pills, so it was confirmedthat there was no destruction of microcapsules.

Comparative Manufacture Example 2M

On the surface of both the upper and lower punches of a double structurewith outside diameter of 8.0 mm and with flat edge, small amount ofmagnesium stearate (the same as before) was applied and, as the lowerpunch was kept in lowered position, 50 mg of granulated product oflactose and crystalline cellulose (the same as before) was supplied;then the upper punch and the lower punch were moved towards each otherand temporary compression was applied manually so as the surface tobecome flat. Next, as the lower punch was kept in lowered position, inthe space over the temporary moldings of lactose and crystallinecellulose in the die, 30 mg of microcapsules (the same as above) weresupplied; then the upper punch and the lower punch were moved towardseach other and temporary compression was applied manually so as thesurface to become flat. Next, in the space over the temporary moldings,made of lactose and crystalline cellulose and microcapsules in the die,40 mg of granulated product of lactose and crystalline cellulose werefed; then the upper punch and the lower punch were moved towards eachother and temporary compression was applied manually so as the surfaceto become flat. Furthermore, in the space above the molding, made in theprevious steps, the remaining 30 mg of microcapsules were fed and theupper punch and the lower punch were moved towards each other andcompression was applied manually so as the surface to become flat.Finally, in the space in the die above the temporary moldings, theremaining 50 mg of lactose and crystalline cellulose were supplied andusing hydraulic type hand press (the same as before), tablets were made,applying on a tablet unit of square measure pressure of 7.9 kg/mm²(approximately 400 kg per punch). The weight of the tablets was 195.4 mgper tablet and the thickness of the tablets was 3.51 mm. When taken outof the die, on the surface (circumference plane) of this tablet therewas a big crack in the microcapsule layer and upon taking hold of themwith hand during or after taking them out, the layer collapsed.

Comparative Manufacture Example 3M

On the surface of both the upper and lower punches of a double structurewith inside diameter of 6.0 mm and outside diameter of 8.0 mm and withflat edge, small amount of magnesium stearate (the same as before) wasapplied and, as the lower central punch was kept in lowered position, inthe space above the lower central punch and enclosed by the lower outerpunch 55 mg of granulated product of lactose and crystalline cellulose(the same as above) were supplied; then the upper central punch and thelower central punch were moved towards each other and temporarycompression was applied manually so as the surface to become flat. Next,as the lower central punch was kept in lowered position, in the spaceabove the temporary moldings of lactose and crystalline cellulose,enclosed by the lower outer layer, 60 mg of microcapsules (the same asabove) were supplied; then the upper central punch and the lower centralpunch were moved towards each other and in the next step of temporarymolding was performed to a degree, which could maintain moldability,enabling smooth transition. Next, as the lower punch was kept in loweredposition, in the die, in the space above and around the temporarymoldings formed in the previous steps, the remaining 85 mg of granulatedproduct of lactose and crystalline cellulose (the same as above) weresupplied and as the temporary moldings of lactose and crystallinecellulose and microcapsules was completely enclosed in the granulatedproduct of lactose and crystalline cellulose, upper punch and lowerpunch were moved towards each other and, using hydraulic type hand press(the same as before), tablets were made, applying on a tablet unit ofsquare measure pressure of 7.9 kg/mm² (approximately 400 kg per punch).The weight of the tablets was 198.8 mg per tablet and the thickness oftablets was 3.56 mm. When taken out of the die, on the surface(circumference plane) of this tablet there was a big crack in themicrocapsule layer and upon taking hold of them with hand during orafter taking them out, the layer collapsed. Besides, on a part of thetablet's surface there was a small amount of microcapsules.

[Evaluation of Friability]

The results of the friability test are shown in Table 4. Despite thefact that manufacture example 1M, comparative manufacture example 1M,comparative manufacture example 2M and comparative manufacture example3M contain the same amount of molding materials of extremely poormoldability and the used excipients are also of same content and amount,and, furthermore, the force of the pressure applied is the same, thedegree of friability differed substantially. As compared withmanufacture example 1, where even after 100 revolutions of the drum,there was almost no friability, in comparative manufacture example 1Mapproximately 10% of the weight of the tablet were worn out.Furthermore, in comparative manufacture example 2M and 3M, immediatelyafter manufacturing the tablets, there were damages in the layer and thefriability couldn't be evaluated so manufacturing of moldings wasimpossible.

TABLE 4 Number of cumulative revolutions of drum Samples 25 50 75 100Manufacture example 1M 0.00% 0.10% 0.25%  0.51% Comparative manufacture0.77% 2.62% 4.27% 10.02% example 1M Comparative manufacture — — — —example 2M Comparative manufacture — — — — example 3M * The numbers (%)in the columns show degree of friability * “—” shows impossibility tomeasure

The main reason for the increase in friability in comparativemanufacture example 1M is the exfoliation of the microcapsules on thesurface of the tablets and the reason for the collapse in the layer incomparative manufacture example 2M is that microcapsules withoutmoldability were distributed up to the outer part of the moldings andthat part became fragile and as a result the moldability of the wholemoldings decreased. Next, the reason for the collapse in the layers incomparative manufacture example 3M is that the large amount ofmicrocapsules without moldability couldn't be supported by the outerlayer alone. These results show that when moldings large amount ofmicrocapsules with poor moldability, if the moldings with core are likethe ones in manufacture example 1M, then friability can be improvedsubstantially.

Experimental Example 6

The results of experimental example 5 showed that the tablets ofmanufacture example 1M possess superb degree of friability. Next,tablets, containing large amount of microcapsules were manufactured bythe conventional method of manufacturing ordinary tablets and theuniformity of the microcapsules' amount in the tablets as well as theirouter look were evaluated.

Comparative Manufacture Example 4M

150 g microcapsules (the same as above) and 345 g granulated product oflactose and crystalline cellulose (the same as above) are mixed insmall-type V-shaped mixer (manufactured by Tsutsui Rikagaku Kiki) at 100revolutions. Then 5 g of magnesium stearate are fed in the mixture andit is mixed again at 50 revolutions. Next, samples are taken from oneplace in the bottom layer, 2 places in the middle layer and 3 places inthe upper layer of the mixture in the small-type V-shaped mixer and areused as samples for measuring the amount of microcapsules.

The mixture samples are made into tablets, using a punch with 6.0 mm indiameter ordinary R and in rotary device for making pills (manufacturedby Kikusui Seisakujo: VIRGO518SSII AZ), applying pressure of 10.6 kg/mm²per tablet unit square measure (approximately 300 kg per punch). Thesetablets were used as samples in comparative manufacture example 4M.These samples were gathered at the beginning of the process of makingthe tablets (0 minute), 10 min, 20 min, 30 min and at the end of theprocess of making the tablets (40 min) and thus approximately 100samples of tablets were made. The average weight of the tablets wasapproximately 78 mg and the thickness of the tablets was approximately3.8 mm. In all samples there was no oozing out of vitamin E on thesurface of the tablets and lack of breaking of microcapsules wasconfirmed.

[Evaluation of Uniformity of Content]

The results of the evaluation of content's uniformity, performed inaccordance with the method for measuring microcapsule content, are shownon table 5. It became clear that when tablets, containing large amountof microcapsules are made in sequence by the traditional methods, theamount of microcapsules in the tablets changes substantially. In otherwords, it became clear that the microcapsule content of the tablets incomparative manufacture example 4M decreased in the beginning of thestep of making tablets and increased in the end of the same step. It wassurmised that this change in the amount followed the following pattern:the microcapsules in the excipients were separated in the upper part dueto the oscillation and the rotation of the device for making tablets andthat is why in the beginning of the process of making tablets theexcipients were in large amount, but with the passage of time theexcipients in the lower part disappeared and the microcapsules, whichexisted in the upper part were filled in the die and that is why theamount increased. Furthermore, the change in the microcapsules amountwas also related to the change in the pressure during the process ofmaking tablets and it became clear that it is extremely difficult toperform stable step of making tablets in sequence.

TABLE 5 Samples of Ratio (%) against comparative Average amount of theaverage manufacture microcapsules (%) amount of example 4M in 1 tabletmixture Mixture 29.7 ± 5.1 100 At the beginning of 34.8 ± 2.0 116.9 ±7.2 tabletting step 0 min 10 min 19.1 ± 1.9  64.2 ± 6.2 20 min 19.0 ±1.5  64.0 ± 5.2 30 min 43.8 ± 2.1 147.2 ± 7.0 At the end of 43.0 ± 0.9144.7 ± 2.9 tabletting step 40 min * The theoretical value ofmicrocapsule content in one tablet is 30%. * The number of samples ofmixture is n = 6, the number of samples of tablets is n = 3 and ± showsstandard deviation

The unevenness in the microcapsule content already became obvious in themixture for measuring microcapsule content and changed according to thedifference of the places of the samples between 24.6 and 34.8% againstthe theoretical amount of molding material (30%). It was confirmed thateven if the time of mixing was changed, the unevenness couldn't beimproved (this data is not shown).

On the other hand, in the present invention, in manufacturing moldinglike the ones shown in manufacture example 1M, the traditional methodsof mixing excipients and microcapsules and then feeding them in the dieare not used, but instead new methods of feeding the microcapsules andexcipients separately in the die are applied and that is why problemssuch as segregation of microcapsules and excipients do not occur. Inother words, the uniformity of content is in compliance with the methodfor testing uniformity of content in 13^(th) revision of JapanesePharmacopoeia, General Testing Methods.

From the results given above it became clear that in the tablets,manufactured following the traditional method for physical mixing, therewas substantial unevenness in the content of microcapsules anduniformity of content couldn't be secured.

[Evaluation of Existence/Nonexistence of both Sides of Tablets]

The results of the measurement of the color difference of both sides ofthe tablets, performed following the above methods, are shown in Table6.

TABLE 6 Samples of comparative Average value of color manufactureexample 4M difference (ΔE) of one tablet At the beginning 0.9 ± 0.6 oftabletting step 0 min 10 min 0.6 ± 0.3 20 min 1.1 ± 0.6 30 min 6.9 ± 1.5At the end of the 5.8 ± 2.2 step of making tablets 40 min * The numberof sample tablets is n = 3, ± shows standard deviation.

This results show that when tablets, containing large amount ofmicrocapsules, are made in sequence, following the traditional method,on both sides of the tablet or in other words on the surface of thetablet appears a large amount of microcapsules. In general, when thecolor difference value exceeds “3”, the difference in the color shouldbe clearly visible, but it became clear that the distinction in bothsides (color difference over 3) appears at the end of the step of makingtablet and is related with the previously described change in thecontent. That distinction in both sides creates problems not only withthe outer look of the tablet, but also shows that microcapsules withoutmoldability are concentrated at the surface of the tablet and thereforearises new problems of abrasion of the microcapsules.

On the other hand, in the molding of the present invention, like theones shown in manufacture example 1M, due to the method if theinvention, microcapsules do not appear in the outer layer and thereforeproblems, typical for the prior art, such as abrasion of microcapsulesfrom the tablets or appearance of microcapsules on the both sides, aresuccessfully avoided.

Up to here the present invention's method for the manufacture of amolding with core, the apparatus necessary for it's application and themolding with core, which are it's product were explained in details, butthe technical scope of the present invention is not limited to the aboveexecution form.

The effectiveness of the present invention could be summarized asfollows: since it enables moldings at once of moldings with core frommolding material as contrasted to the supplying of core, manufacturedbeforehand as moldings, the present invention has not only highproduction efficiency, but also enables to avoid different troublesrelated to the core and makes possible the manufacturing of molding withextremely low levels of unevenness and high precision which guaranteeshigh quality of the product.

Furthermore, in the present invention it is possible to manufacturemoldings with core, where the core is made of molding material thatcouldn't be molded by the traditional method and also to apply thealternative method of film coating, used in the field of medicalproducts for masking the bitter taste, improving the outer look andelution control.

1. A method for manufacturing a molding with a core using compressionmolding means that comprises an upper punch and a lower punch which arearranged in the vertical direction of a die, wherein both the upperpunch and the lower punch have a double structure comprising a centralpunch and an outer punch surrounding the outer periphery of the centralpunch, wherein both the central punch and the outer punch are capable ofcompressing operations as well as sliding motions, the method comprisingfollowing steps in this order: an outer layer supply step 1 of supplyinga molding material for outer layer into a space above the lower centralpunch enclosed by the lower outer punch with the lower central punchbeing in its lowered position; an outer layer molding step ofcompression-molding the molding material for outer layer by moving theupper central punch and the lower central punch toward each other; acore supply step of supplying a molding material for core into a spaceabove the molding material for outer layer supplied in the precedingstep enclosed by the lower outer punch with the lower central punchbeing in its lowered position; an outer layer and core molding step ofcompression-molding the molding material for outer layer and the moldingmaterial for core supplied in the precedent steps by moving the uppercentral punch and the lower central punch toward each other; an outerlayer supply step 2 of supplying a molding material for outer layer intoa space in a die above and around the outer layer and core moldingformed in the precedent step so as to allow the core molding tocompletely be enveloped by the molding material for outer layer and theouter layer molding; and a whole molding step of compression-molding theouter layer and core molding and the molding material for outer layer bymoving the upper punch and the lower punch toward each other.
 2. Themethod for manufacturing a molding with a core according to claim 1,wherein a residual molding material removing step of removing moldingmaterial residue left on the lower outer punch is effected after thesupply of molding material or during compression molding thereof orafter the compression molding thereof, excepting most recently suppliedmolding material for outer layer.
 3. The method for manufacturing amolding with a core according to claim 2, wherein the molding materialused is in the form of powder or granules.
 4. The method formanufacturing a molding with a core according to claim 3, wherein themolding includes plural cores, and wherein the method further comprises,after the core supply step of supplying a molding material for core,outer layer/core repeated supply steps of supplying a molding materialfor core or a molding material for outer layer into a space above themolding material supplied in the preceding step enclosed by the lowerouter punch with the lower central punch being in its lowered positionand, each time after the outer layer/core repeated supply steps, anouter layer/core repeated molding steps of compression-molding themolding material(s) supplied in the precedent steps by moving the uppercentral punch and the lower central punch toward each other.
 5. Themethod for manufacturing a molding with a core according to claim 4,wherein the molding has cores including microcapsular granule andmicrocapsular granule is used as the molding material for core, andwherein outer layer supply step and microcapsular granule (as moldingmaterial for core) supply step thereafter are effected as core outerlayer/core repeated supply steps.
 6. The method for manufacturing amolding with a core according to claim 2, wherein the molding includesplural cores, and wherein the method further comprises, after the coresupply step of supplying a molding material for core, outer layer/corerepeated supply steps of supplying a molding material for core or amolding material for outer layer into a space above the molding materialsupplied in the preceding step enclosed by the lower outer punch withthe lower central punch being in its lowered position and, each timeafter the outer layer/core repeated supply steps, an outer layer/corerepeated molding steps of compression-molding the molding material(s)supplied in the precedent steps by moving the upper central punch andthe lower central punch toward each other.
 7. The method formanufacturing a molding with a core according to claim 6, wherein themolding has cores including microcapsular granule and microcapsulargranule is used as the molding material for core, and wherein outerlayer supply step and microcapsular granule (as molding material forcore) supply step thereafter are effected as core outer layer/corerepeated supply steps.
 8. The method for manufacturing a molding with acore according to claim 1, wherein the molding material used is in theform of powder or granules.
 9. The method for manufacturing a moldingwith a core according to claim 1, wherein the molding includes pluralcores, and wherein the method further comprises, after the core supplystep of supplying a molding material for core, outer layer/core repeatedsupply steps of supplying a molding material for core or a moldingmaterial for outer layer into a space above the molding materialsupplied in the preceding step enclosed by the lower outer punch withthe lower central punch being in its lowered position and, each timeafter the outer layer/core repeated supply steps, an outer layer/corerepeated molding steps of compression-molding the molding material(s)supplied in the precedent steps by moving the upper central punch andthe lower central punch toward each other.
 10. The method formanufacturing a molding with a core according to claim 9, wherein themolding has cores including microcapsular granule and microcapsulargranule is used as the molding material for core, and wherein outerlayer supply step and microcapsular granule (as molding material forcore) supply step thereafter are effected as core outer layer/corerepeated supply steps.
 11. A method for manufacturing a molding with acore using compression molding means that comprises an upper punch and alower punch which are arranged in the vertical direction of a die,wherein both the upper punch and the lower punch have a double structurecomprising a central punch and an outer punch surrounding the outerperiphery of the central punch, wherein both the central punch and theouter punch are capable of compressing operations as well as slidingmotions, the method comprising following steps in this order: an outerlayer supply step 1 of supplying a molding material for outer layer intoa space for the outer layer above the lower central punch enclosed bythe lower outer punch with the lower central punch being in its loweredposition; a step of discharging excess molding material for outer layerout of the die; an outer layer molding step of compression-molding thesupplied molding material for outer layer by moving the upper centralpunch and the lower central punch toward each other; a residual moldingmaterial removing step of removing molding material residue left on thelower outer punch after the supply of molding material for outer layeror during compression molding thereof or after the compression moldingthereof; a core supply step of supplying a molding material for coreinto a space for core above the molded material for outer layer enclosedby the lower outer punch with the lower central punch being in itslowered position; a step of discharging excess molding material for coreout of the die; an outer layer and core molding step ofcompression-molding the supplied molding material for core and themolded material for outer layer by moving the upper central punch andthe lower central punch toward each other; a residual molding materialremoving step of removing molding material residue left on the lowerouter punch after the supply of molding material for core or duringcompression molding thereof or after the compression molding thereof; anouter layer supply step 2 of supplying a molding material for outerlayer into a space for outer layer in a die above and around the outerlayer and core molding so as to allow the core molding to completely beenveloped by the molding material for outer layer and the moldedmaterial for outer layer; a step of discharging excess molding materialfor outer layer out of the die; a whole molding step ofcompression-molding the whole of outer layer and core by moving theupper punch and the lower punch toward each other; and a step of takingout the compressed molding.